## Protocol Section
### Identification Module
**NCT ID:** NCT01294579

**Brief Title:** Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL)

**Official Title:** A Phase II Open-Label Study of Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL) Which Has Relapsed After Rituximab or a Rituximab Containing Therapy

#### Organization Study ID Info
**ID:** 114612
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2016-12-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-08-09

**Type:** ACTUAL

**Results First Submit Date:** 2017-12-15

**Results First Submit QC Date:** 2018-08-06

#### Start Date
**Date:** 2011-05-17

**Type:** ACTUAL

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2011-02-11
**Type:** ESTIMATED
**Study First Submit Date:** 2011-02-03
**Study First Submit QC Date:** 2011-02-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this phase II open label study was is to evaluate the safety and efficacy of ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent B-NHL who had relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years old with Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, or follicular lymphoma; Grades 1, 2 and 3a, would have been enrolled (34 in Stage 1 and 19 in Stage 2). Subjects should have had Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following completion of therapy or subjects should have relapsed or have had disease progression following response to prior rituximab-based therapy a Eastern Cooperative Oncology Group (ECOG) Performance status of 0 1 or 2. During the induction phase, ofatumumab 1000 mg IV on day 1 of each cycle (cycles 1-6) were followed by Bendamustine 90 mg/m2 IV on days 1, 2 of each cycle (cycles 1-6).During the maintenance phase, subjects with a PR or CR after the induction phase received ofatumumab 1000 mg IV every 2 months for 2 years.

### Conditions Module

**Conditions:**

- Lymphoma, Non-Hodgkin

**Keywords:**

- Non-Hodgkin's Lymphoma

- Ofatumumab

- Relapsed

- Rituximab

- Bendamustine

### Design Module

#### Design Info

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 49

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years.

Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)

**Intervention Names:**

- Biological: Ofatumumab

- Drug: Bendamustine

**Label:** ofatumumab and bendamustine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ofatumumab and bendamustine

**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase

1000 mg IV every 2 months for 2 years

**Name:** Ofatumumab

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- ofatumumab and bendamustine

**Description:** 90 mg/m2 on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)

**Name:** Bendamustine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and \>1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.

**Measure:** Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS)

**Time Frame:** Baseline up to 24 weeks

#### Secondary Outcomes

**Description:** The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: \> or = to 50% decrease from baseline in target nodules; \> or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease.

**Measure:** Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS)

**Time Frame:** Baseline up to 24 weeks

**Description:** Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine

**Measure:** Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS)

**Time Frame:** Partial response in induction phase up to 24 weeks

**Description:** Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to \>2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to \>2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to \>2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis \>1.5 cm.

**Measure:** Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)

**Time Frame:** Baseline up to approximately 30 months

**Description:** Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates.

**Measure:** Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS)

**Time Frame:** Baseline up to approximately 30 months

**Description:** Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done.

**Measure:** Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell

**Time Frame:** up to 30 months

**Description:** Deaths were collected and were considered to be an on treatment death up to 60 days post treatment.

**Measure:** All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months

**Time Frame:** Baseline up to approximately 30 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Signed written informed consent
* Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, and follicular lymphoma; Grades 1, 2 and 3a, defined according to World Health organization (WHO) guidelines. \[Tefferi, 2008\]
* Tumor was verified to be CD20+ (based on local evaluation), from a current or previous tissue biopsy. Tissue biopsy should be repeated if no report or specimen is available, CD20 staining was not previously performed, or there is clinical suspicion that the indolent lymphoma has transformed to aggressive lymphoma/higher malignancy grade.
* Rituximab-sensitive disease, defined as a Partial Remission (PR) or Complete Remission (CR) to the last rituximab-containing therapy lasting at least 6 months following completion of therapy. Last rituximab-containing therapy is defined as the last therapy regimen containing at least one full dose of rituximab.
* Relapse or disease progression following response to prior rituximab-based therapy, that requiried treatment by 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) guidelines.
* CT imaging in screening (based on local evaluation) showing 2 or more clearly demarcated lesions with a largest diameter \> 1.5 cm, or 1 clearly demarcated lesion with a largest diameter \> 2.0 cm.
* ECOG Performance Status of 0, 1, or 2.
* Age ≥ 18 years.
* Life expectancy of at least 6 months in the opinion of the investigator.
* Women of childbearing potential must have had a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception during the study and for one year following the last dose of study drug.
* Men with a female partner of childbearing potential must have had either had a prior vasectomy or agree to use effective contraception from 2 weeks prior to administration of the first dose of study treatment until one year after the last dose of study treatment.
* Must not have been on any prohibited medications.
* Subjects who had received prior bendamustine were eligible if they had achieved a response (CR/PR) which lasted \> 6 months after the end of bendamustine containing treatment.

Exclusion Criteria:

* Lactating women
* CLL, Grade 3b follicular lymphoma or evidence that the indolent lymphoma had transformed to aggressive lymphoma. Subjects suspicious for transformation should have undergone a biopsy to exclude the possibility of transformation. Subjects with a previous diagnosis of small lymphocytic leukemia (SLL) and a screening monoclonal B-lymphocyte count of ≥ 5000/µl are defined by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria to have CLL; such patients were NOT eligible for this study.
* Rituximab-refractory disease, defined as failure to have responded to or progression within 6 months of completing rituximab or rituximab-containing combination therapy.
* Previous treatment with ofatumumab.
* Previous radioimmunotherapy (RIT) within 6 months of study entry. Subjects who have received RIT must have attained a PR or CR lasting at least 6 months, and must have recovered from any hematologic or other toxicity.
* Previous allogeneic stem cell transplantation at any time OR autologous stem cell transplantation within 6 months of study entry.
* Prior use of monoclonal antibody (other than anti CD20) within 3 months prior to randomization. Chemotherapy or other systemic lymphoma therapy within 4 weeks of study entry.
* Received treatment with an investigational agent within 4 weeks of study entry, or was actively participating in another interventional clinical study.
* Known Central Nervous System (CNS) involvement by lymphoma.
* Current or previous other malignancy within 2 years of study entry. Exception: Subjects who have been disease-free for 2 years or more, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Chronic or currently active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment including, but not limited to: chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis C, and known HIV disease. All Human Immunodeficient virus (HIV)-positive subjects are excluded from this study, regardless of whether they have an Acquired Immunodeficiency Syndrome (AIDS) defining disease and/or are on antiviral therapy.
* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months of study entry, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Subjects with congestive heart disease or arrhythmia such as atrial fibrillation whose cardiac disease is well controlled on a stable medical regimen are eligible.
* Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the Investigator's opinion, will impact study participation.
* Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but (Hepatitis B core antibody (HBcAb) positive (regardless of Hepatitis B surface antibody \[HBsAb\] status), a HB DNA test had to have been performed and if positive the subject will be excluded. If HBV DNA is negative, subject may be included but must have undergone HBV DNA monitoring. Prophylactic antiviral therapy may have been initiated at the discretion of the investigator.
* Current active liver or biliary disease. Exception: Subjects with Gilbert's syndrome or asymptomatic gallstones, liver metastases related to indolent NHL or otherwise stable chronic liver disease per investigator assessment, are eligible.
* Screening laboratory values:

Neutrophils \< 1.5 x 109/L (unless due to NHL involvement of the bone marrow). Platelets \< 100 x 109/L (unless due to NHL involvement of the bone marrow). Serum creatinine ≥2.0 mg/dL; subjects with serum creatinine ≥2.0 mg/dL were are eligible if the creatinine clearance (Cockcroft Gault equation \[Cockcroft, 1976\]) is ≥40 mL/min.

Total bilirubin \> 1.5 times ULN \[upper normal limit\] (unless due to liver involvement by NHL or Gilbert's disease).

Transaminases \> 3 times ULN (unless due to NHL involvement).

* Known or suspected inability to fully comply with study protocol.
* Known or suspected hypersensitivity to ofatumumab, bendamustine or mannitol.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chandler

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Arizona

**Zip:** 85224

**Location 2:**

**City:** Burbank

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** California

**Zip:** 91505

**Location 3:**

**City:** Fresno

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** California

**Zip:** 93720

**Location 4:**

**City:** Oxnard

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** California

**Zip:** 93030

**Location 5:**

**City:** Aurora

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Colorado

**Zip:** 80045

**Location 6:**

**City:** Orange Park

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Florida

**Zip:** 32073

**Location 7:**

**City:** Burlington

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Massachusetts

**Zip:** 01805

**Location 8:**

**City:** Omaha

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Nebraska

**Zip:** 68198-9200

**Location 9:**

**City:** Las Vegas

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Nevada

**Zip:** 89169

**Location 10:**

**City:** Cary

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** North Carolina

**Zip:** 27518

**Location 11:**

**City:** Charlotte

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** North Carolina

**Zip:** 28204

**Location 12:**

**City:** Raleigh

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** North Carolina

**Zip:** 27607

**Location 13:**

**City:** Kettering

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Ohio

**Zip:** 45429

**Location 14:**

**City:** Eugene

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Oregon

**Zip:** 97401

**Location 15:**

**City:** Charleston

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** South Carolina

**Zip:** 29414

**Location 16:**

**City:** Greenville

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** South Carolina

**Zip:** 29601

**Location 17:**

**City:** San Antonio

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Texas

**Zip:** 78229

**Location 18:**

**City:** Sherman

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Texas

**Zip:** 75090

**Location 19:**

**City:** Tyler

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Texas

**Zip:** 75702

**Location 20:**

**City:** Waco

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Texas

**Zip:** 76712

**Location 21:**

**City:** Vancouver

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Washington

**Zip:** 98684

**Location 22:**

**City:** Yakima

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** Washington

**Zip:** 98902

#### Overall Officials

**Official 1:**

**Affiliation:** Novartis Pharmaceuticals

**Name:** Novartis Pharmaceuticals

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Lyons RM, Shtivelband M, Kingsley E, Moezi M, Richards D, Sharman J, Feng X, Cannan M, Fellague-Chebra R, Boyd TE. Efficacy and safety of ofatumumab and bendamustine followed by ofatumumab maintenance in patients with relapsed indolent non-Hodgkin lymphoma after prior rituximab. Leuk Lymphoma. 2021 Jun;62(6):1353-1360. doi: 10.1080/10428194.2020.1869957. Epub 2021 Jan 15.

**PMID:** 33448893

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: HIGH

- As Found: Lymphoma, Non-Hodgkin

- ID: M18828

- Name: Lymphoma, B-Cell

- Relevance: HIGH

- As Found: B-Cell Non-Hodgkin Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T640

- Name: B-cell Lymphoma

- Relevance: HIGH

- As Found: B-Cell Non-Hodgkin Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

- ID: D000016393

- Term: Lymphoma, B-Cell

### Intervention Browse Module - Ancestors

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M430

- Name: Bendamustine Hydrochloride

- Relevance: HIGH

- As Found: Action

- ID: M373

- Name: Rituximab

- Relevance: LOW

- As Found: Unknown

- ID: M347498

- Name: Ofatumumab

- Relevance: HIGH

- As Found: Lunch

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069461

- Term: Bendamustine Hydrochloride

- ID: C000527517

- Term: Ofatumumab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Deaths are reported as a secondary outcome

#### Event Groups

**Group ID:** EG000

**Title:** Ofatumumab + Bendamustine

**Deaths Num Affected:** 7

**Deaths Num At Risk:** 49

**Description:** Ofatumumab + Bendamustine

**ID:** EG000

**Other Num Affected:** 47

**Other Num at Risk:** 49

**Serious Number Affected:** 18

**Serious Number At Risk:** 49

**Title:** Ofatumumab + Bendamustine

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** External ear pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Mucosal inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Sinusitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Contusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (19.0)

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Lymphocyte count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Hyperuricaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Vitamin D deficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Bone pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pollakiuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Throat irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Night sweats

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Urticaria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Flushing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

#### Serious Events

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 49

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Gastric ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 49

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 49

**Term:** Anaphylactic reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Diverticulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Infected skin ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Neutropenic sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 49

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Electrocardiogram QT prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Failure to thrive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Rhabdomyolysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Myelodysplastic syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 49

**Term:** Prostate cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Squamous cell carcinoma of lung

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Squamous cell carcinoma of skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 49

**Time Frame:** Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 49

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ofatumumab and Bendamustine

**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.61

**Value:** 66.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 35

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

**Class Title:** African American/African heritage

#### Measurement

**Group ID:** BG000

**Value:** 45

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** Mixed race

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The study was terminated early based on the evolution of the current therapeutic treatment landscape in Non Hodgkin Indolent Lymphomas and low enrollment rates for this trial.
### Point of Contact
**Email:** Novartis.email@novartis.com
**Organization:** Novartis Pharmaceuticals
**Phone:** 862-778-8300
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.3
- **Spread:** 
- **Upper Limit:** 38.9
- **Value:** 24.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 52.5
- **Spread:** 
- **Upper Limit:** 80.1
- **Value:** 67.3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.2
- **Spread:** 
- **Upper Limit:** 64.6
- **Value:** 37.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** Upper limit of CI was not estimable
- **Group ID:** OG000
- **Lower Limit:** 17.3
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 29.7
**Title:** 
#### Outcome Measure 6
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and \>1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline up to 24 weeks
**Title:** Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
#### Outcome Measure 2
**Description:** The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: \> or = to 50% decrease from baseline in target nodules; \> or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline up to 24 weeks
**Title:** Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
#### Outcome Measure 3
**Description:** Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Partial response in induction phase up to 24 weeks
**Title:** Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
#### Outcome Measure 4
**Description:** Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to \>2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to \>2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to \>2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis \>1.5 cm.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline up to approximately 30 months
**Title:** Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
#### Outcome Measure 5
**Description:** Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Baseline up to approximately 30 months
**Title:** Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
#### Outcome Measure 6
**Description:** Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done.
**Reporting Status:** POSTED
**Time Frame:** up to 30 months
**Title:** Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell
**Type:** SECONDARY
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
#### Outcome Measure 7
**Description:** Deaths were collected and were considered to be an on treatment death up to 60 days post treatment.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline up to approximately 30 months
**Title:** All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** OG000
**Title:** Ofatumumab and Bendamustine
### Participant Flow Module
#### Group
**Description:** 1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase and 1000 mg IV every 2 months for 2 years. Bendamustine 90 mg/m2 was given on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
**ID:** FG000
**Title:** Ofatumumab and Bendamustine
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Disease progression
###### Reason
**Group ID:** FG000
**Number of Subjects:** 12
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
##### Withdraw
**Type:** Study closed/terminated
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 49
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
**Pre-Assignment Details:** Subjects completed represents subjects who completed treatment.
**Has Results:** True