## Protocol Section
### Identification Module
**NCT ID:** NCT06425302

**Acronym:** GOLSEEK-2

**Brief Title:** A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

**Official Title:** A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

#### Organization Study ID Info
**ID:** CA073-1022
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
#### Secondary ID Infos
**Domain:** WHO
**ID:** U1111-1303-4594
**Type:** OTHER
**Domain:** EU CTR
**ID:** 2024-511304-16
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-11-27

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-11-23

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Celgene

#### 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 study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

### Conditions Module

**Conditions:**

- Lymphoma, Follicular

**Keywords:**

- Follicular lymphoma

- Grade 1-3a Follicular lymphoma

- BMS-986369

- CC-99282

- Lymphoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine

**Intervention Names:**

- Drug: Rituximab

- Drug: Cyclophosphamide

- Drug: Doxorubicin

- Drug: Vincristine

- Drug: Prednisone

- Drug: Bendamustine

**Label:** Rituximab + Chemotherapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Golcadomide

- Drug: Rituximab

**Label:** Golcadomide Dose 1 + Rituximab

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: Golcadomide

- Drug: Rituximab

**Label:** Golcadomide Dose 2 + Rituximab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Golcadomide Dose 1 + Rituximab

- Golcadomide Dose 2 + Rituximab

**Description:** Specified dose on specified days

**Name:** Golcadomide

**Other Names:**

- CC-99282

- BMS-986369

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Golcadomide Dose 1 + Rituximab

- Golcadomide Dose 2 + Rituximab

- Rituximab + Chemotherapy

**Description:** Specified dose on specified days

**Name:** Rituximab

**Other Names:**

- Mabthera

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Rituximab + Chemotherapy

**Description:** Specified dose on specified days

**Name:** Cyclophosphamide

**Other Names:**

- Endoxan

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Rituximab + Chemotherapy

**Description:** Specified dose on specified days

**Name:** Doxorubicin

**Other Names:**

- Caelyx

- pegylated liposomal doxorubicin

- PLD

**Type:** DRUG

#### Intervention 5

**Arm Group Labels:**

- Rituximab + Chemotherapy

**Description:** Specified dose on specified days

**Name:** Vincristine

**Type:** DRUG

#### Intervention 6

**Arm Group Labels:**

- Rituximab + Chemotherapy

**Description:** Specified dose on specified days

**Name:** Prednisone

**Type:** DRUG

#### Intervention 7

**Arm Group Labels:**

- Rituximab + Chemotherapy

**Description:** Specified dose on specified days

**Name:** Bendamustine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Golcadomide + Rituximab arms only

**Measure:** Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014

**Time Frame:** Up to approximately 12 months from participant randomization

#### Secondary Outcomes

**Measure:** Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0

**Time Frame:** Up to 28 days after last dose

**Measure:** Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0

**Time Frame:** Up to 28 days after last dose

**Description:** Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014

**Measure:** Best Overall Response (OR)

**Time Frame:** Up to approximately 12 months from participant randomization

**Description:** Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death

**Measure:** Duration of Response (DoR)

**Time Frame:** Up to approximately 3 years after randomization of the last participant

**Description:** Defined as achieving CR based on Lugano criteria at 30 months from randomization

**Measure:** Complete Response at 30 months (CR30)

**Time Frame:** At approximately 30 months from randomization

**Description:** Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization

**Measure:** Complete Metabolic Response at 6 months from the randomization (CMR6)

**Time Frame:** At approximately 6 months from randomization

**Description:** Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization

**Measure:** Complete Metabolic Response at 12 months from the randomization (CMR12)

**Time Frame:** At approximately 12 months from randomization

**Description:** Defined as time from date of randomization to first occurrence of disease progression or death from any cause

**Measure:** Progression Free Survival (PFS)

**Time Frame:** Up to approximately 3 years from randomization of last participant

**Description:** Defined as time from date of randomization to death from any cause

**Measure:** Overall Survival (OS)

**Time Frame:** Up to approximately 3 years from randomization of last participant

**Description:** Rituximab + Chemotherapy arm only

**Measure:** Number of participants who achieve CMR as assessed by Lugano criteria 2014

**Time Frame:** Up to approximately 6 months from randomization

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.

  i) Bulky disease defined as:.

A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).

ii) Presence of at least one of the following B symptoms:.

A. Fever (\>38°C) of unclear etiology.

B. Night sweats.

C. Weight loss greater than 10% within the prior 6 months.

iii) Splenomegaly with inferior margin below the umbilical line.

iv) Any one of the following cytopenia due to lymphoma:.

A. Platelets \<100,000 cells/mm3 (100 x 109/L).

B. Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L).

C. Hemoglobin \< 10g/dL (6.25 mmol/L).

v) Pleural or peritoneal serous effusion (irrespective of cell content)

vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal)

Exclusion Criteria:

* Clinical evidence of transformed lymphoma by investigator assessment.
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain the NCT# and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Birmingham

**Contacts:**

***Contact 1:***

- **Name:** Site 0152

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0152

**State:** Alabama

**Zip:** 35294-3300

**Location 2:**

**City:** Anchorage

**Contacts:**

***Contact 1:***

- **Name:** Site 0055

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0055

**State:** Alaska

**Zip:** 99508

**Location 3:**

**City:** Phoenix

**Contacts:**

***Contact 1:***

- **Name:** Site 0180

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0180

**State:** Arizona

**Zip:** 85054

**Location 4:**

**City:** Tucson

**Contacts:**

***Contact 1:***

- **Name:** Site 0190

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0190

**State:** Arizona

**Zip:** 85711

**Location 5:**

**City:** San Francisco

**Contacts:**

***Contact 1:***

- **Name:** Site 0035

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0035

**State:** California

**Zip:** 94143

**Location 6:**

**City:** Washington

**Contacts:**

***Contact 1:***

- **Name:** Site 0022

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0022

**State:** District of Columbia

**Zip:** 20007

**Location 7:**

**City:** Jacksonville

**Contacts:**

***Contact 1:***

- **Name:** Site 0005

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0005

**State:** Florida

**Zip:** 32224

**Location 8:**

**City:** Tampa

**Contacts:**

***Contact 1:***

- **Name:** Site 0026

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0026

**State:** Florida

**Zip:** 33606

**Location 9:**

**City:** Peoria

**Country:** United States

**Facility:** Local Institution - 0013

**State:** Illinois

**Zip:** 61615

**Location 10:**

**City:** Fairway

**Contacts:**

***Contact 1:***

- **Name:** Site 0019

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0019

**State:** Kansas

**Zip:** 66205

**Location 11:**

**City:** Jefferson

**Contacts:**

***Contact 1:***

- **Name:** Site 0173

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0173

**State:** Louisiana

**Zip:** 70121

**Location 12:**

**City:** Baltimore

**Contacts:**

***Contact 1:***

- **Name:** Site 0033

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0033

**State:** Maryland

**Zip:** 21287

**Location 13:**

**City:** Boston

**Country:** United States

**Facility:** Local Institution - 0001

**State:** Massachusetts

**Zip:** 02114

**Location 14:**

**City:** Boston

**Contacts:**

***Contact 1:***

- **Name:** Site 0004

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0004

**State:** Massachusetts

**Zip:** 02114

**Location 15:**

**City:** Rochester

**Contacts:**

***Contact 1:***

- **Name:** Site 0031

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0031

**State:** Minnesota

**Zip:** 55905

**Location 16:**

**City:** Henderson

**Contacts:**

***Contact 1:***

- **Name:** Site 0111

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0111

**State:** Nevada

**Zip:** 89074

**Location 17:**

**City:** Hackensack

**Contacts:**

***Contact 1:***

- **Name:** Site 0183

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0183

**State:** New Jersey

**Zip:** 07601

**Location 18:**

**City:** New Brunswick

**Country:** United States

**Facility:** Local Institution - 0020

**State:** New Jersey

**Zip:** 08903

**Location 19:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Name:** Site 0036

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0036

**State:** New York

**Zip:** 10029

**Location 20:**

**City:** Salt Lake City

**Contacts:**

***Contact 1:***

- **Name:** Site 0052

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0052

**State:** Utah

**Zip:** 84106

**Location 21:**

**City:** Norfolk

**Country:** United States

**Facility:** Local Institution - 0200

**State:** Virginia

**Zip:** 23502

**Location 22:**

**City:** Norfolk

**Contacts:**

***Contact 1:***

- **Name:** Site 0201

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0201

**State:** Virginia

**Zip:** 23502

**Location 23:**

**City:** Seattle

**Contacts:**

***Contact 1:***

- **Name:** Site 0166

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0166

**State:** Washington

**Zip:** 98104

**Location 24:**

**City:** Seattle

**Contacts:**

***Contact 1:***

- **Name:** Site 0202

- **Role:** CONTACT

**Country:** United States

**Facility:** Local Institution - 0202

**State:** Washington

**Zip:** 98109

**Location 25:**

**City:** Liverpool

**Contacts:**

***Contact 1:***

- **Name:** Site 0046

- **Role:** CONTACT

**Country:** Australia

**Facility:** Local Institution - 0046

**State:** New South Wales

**Zip:** 2170

**Location 26:**

**City:** Brisbane

**Contacts:**

***Contact 1:***

- **Name:** Site 0070

- **Role:** CONTACT

**Country:** Australia

**Facility:** Local Institution - 0070

**State:** Queensland

**Zip:** 4101

**Location 27:**

**City:** Traralgon

**Contacts:**

***Contact 1:***

- **Name:** Site 0181

- **Role:** CONTACT

**Country:** Australia

**Facility:** Local Institution - 0181

**State:** Victoria

**Zip:** 3844

**Location 28:**

**City:** Porto Alegre

**Contacts:**

***Contact 1:***

- **Name:** Site 0061

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Local Institution - 0061

**State:** Rio Grande Do Sul

**Zip:** 90035-903

**Location 29:**

**City:** Sao Paulo

**Contacts:**

***Contact 1:***

- **Name:** Site 0058

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Local Institution - 0058

**State:** São Paulo

**Zip:** 04543-000

**Location 30:**

**City:** Rio de Janeiro

**Contacts:**

***Contact 1:***

- **Name:** Site 0060

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Local Institution - 0060

**Zip:** 22250-905

**Location 31:**

**City:** São Paulo

**Contacts:**

***Contact 1:***

- **Name:** Site 0056

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Local Institution - 0056

**Zip:** 05652-900

**Location 32:**

**City:** Toronto

**Contacts:**

***Contact 1:***

- **Name:** Site 0064

- **Role:** CONTACT

**Country:** Canada

**Facility:** Local Institution - 0064

**State:** Ontario

**Zip:** M5G 2M9

**Location 33:**

**City:** Santiago

**Contacts:**

***Contact 1:***

- **Name:** Site 0049

- **Role:** CONTACT

**Country:** Chile

**Facility:** Local Institution - 0049

**State:** Región Metropolitana De Santiago

**Zip:** 7500921

**Location 34:**

**City:** Santiago

**Contacts:**

***Contact 1:***

- **Name:** Site 0050

- **Role:** CONTACT

**Country:** Chile

**Facility:** Local Institution - 0050

**State:** Región Metropolitana De Santiago

**Zip:** 7580206

**Location 35:**

**City:** Saint-Cloud

**Contacts:**

***Contact 1:***

- **Name:** Site 0101

- **Role:** CONTACT

**Country:** France

**Facility:** Local Institution - 0101

**State:** Hauts-de-Seine

**Zip:** 92210

**Location 36:**

**City:** Lille

**Contacts:**

***Contact 1:***

- **Name:** Site 0103

- **Role:** CONTACT

**Country:** France

**Facility:** Local Institution - 0103

**State:** Nord

**Zip:** 59000

**Location 37:**

**City:** Poitiers

**Contacts:**

***Contact 1:***

- **Name:** Site 0121

- **Role:** CONTACT

**Country:** France

**Facility:** Local Institution - 0121

**State:** Vienne

**Zip:** 86021

**Location 38:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Site 0118

- **Role:** CONTACT

**Country:** France

**Facility:** Local Institution - 0118

**Zip:** 75010

**Location 39:**

**City:** Regensburg

**Contacts:**

***Contact 1:***

- **Name:** Site 0197

- **Role:** CONTACT

**Country:** Germany

**Facility:** Local Institution - 0197

**State:** Bayern

**Zip:** 93049

**Location 40:**

**City:** Chemnitz

**Contacts:**

***Contact 1:***

- **Name:** Site 0188

- **Role:** CONTACT

**Country:** Germany

**Facility:** Local Institution - 0188

**State:** Sachsen

**Zip:** 09116

**Location 41:**

**City:** Dresden

**Contacts:**

***Contact 1:***

- **Name:** Site 0189

- **Role:** CONTACT

**Country:** Germany

**Facility:** Local Institution - 0189

**Zip:** 01307

**Location 42:**

**City:** Rome

**Contacts:**

***Contact 1:***

- **Name:** Site 0198

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0198

**State:** Lazio

**Zip:** 00133

**Location 43:**

**City:** Rozzano

**Contacts:**

***Contact 1:***

- **Name:** Site 0179

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0179

**State:** Milano

**Zip:** 20089

**Location 44:**

**City:** Bari

**Country:** Italy

**Facility:** Local Institution - 0096

**State:** Puglia

**Zip:** 70124

**Location 45:**

**City:** Bari

**Country:** Italy

**Facility:** Local Institution - 0098

**State:** Puglia

**Zip:** 70124

**Location 46:**

**City:** Bari

**Country:** Italy

**Facility:** Local Institution - 0097

**Zip:** 70124

**Location 47:**

**City:** Bologna

**Contacts:**

***Contact 1:***

- **Name:** Site 0076

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0076

**Zip:** 40138

**Location 48:**

**City:** Napoli

**Contacts:**

***Contact 1:***

- **Name:** Site 0075

- **Role:** CONTACT

**Country:** Italy

**Facility:** Local Institution - 0075

**Zip:** 80131

**Location 49:**

**City:** Hwasun Gun

**Contacts:**

***Contact 1:***

- **Name:** Site 0104

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Local Institution - 0104

**State:** Jeonranamdo

**Zip:** 58128

**Location 50:**

**City:** Busan

**Contacts:**

***Contact 1:***

- **Name:** Site 0100

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Local Institution - 0100

**State:** Pusan-Kwangyǒkshi

**Zip:** 49241

**Location 51:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Site 0085

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Local Institution - 0085

**State:** Seoul-teukbyeolsi [Seoul]

**Zip:** 03080

**Location 52:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Site 0086

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Local Institution - 0086

**State:** Seoul-teukbyeolsi [Seoul]

**Zip:** 06351

**Location 53:**

**City:** Bydgoszcz

**Contacts:**

***Contact 1:***

- **Name:** Site 0186

- **Role:** CONTACT

**Country:** Poland

**Facility:** Local Institution - 0186

**State:** Kujawsko-pomorskie

**Zip:** 85-168

**Location 54:**

**City:** Warszawa

**Contacts:**

***Contact 1:***

- **Name:** Site 0185

- **Role:** CONTACT

**Country:** Poland

**Facility:** Local Institution - 0185

**State:** Mazowieckie

**Zip:** 01-748

**Location 55:**

**City:** Skorzewo

**Contacts:**

***Contact 1:***

- **Name:** Site 0187

- **Role:** CONTACT

**Country:** Poland

**Facility:** Local Institution - 0187

**State:** Wielkopolskie

**Zip:** 60-185

**Location 56:**

**City:** Palma

**Contacts:**

***Contact 1:***

- **Name:** Site 0196

- **Role:** CONTACT

**Country:** Spain

**Facility:** Local Institution - 0196

**State:** Balears [Baleares]

**Zip:** 07120

**Location 57:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Name:** Site 0192

- **Role:** CONTACT

**Country:** Spain

**Facility:** Local Institution - 0192

**State:** Valenciana, Comunitat

**Zip:** 46017

**Location 58:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Site 0191

- **Role:** CONTACT

**Country:** Spain

**Facility:** Local Institution - 0191

**Zip:** 28040

**Location 59:**

**City:** Kaohsiung

**Contacts:**

***Contact 1:***

- **Name:** Site 0094

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Local Institution - 0094

**Zip:** 807

**Location 60:**

**City:** Kaohsiung

**Contacts:**

***Contact 1:***

- **Name:** Site 0092

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Local Institution - 0092

**Zip:** 83301

**Location 61:**

**City:** Taipei

**Contacts:**

***Contact 1:***

- **Name:** Site 0123

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Local Institution - 0123

**Zip:** 10002

**Location 62:**

**City:** Southampton

**Contacts:**

***Contact 1:***

- **Name:** Site 0175

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Local Institution - 0175

**State:** Hampshire

**Zip:** SO16 0YD

**Location 63:**

**City:** Canterbury

**Contacts:**

***Contact 1:***

- **Name:** Site 0112

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Local Institution - 0112

**State:** Kent

**Zip:** CT1 3NG

**Location 64:**

**City:** Edinburgh

**Contacts:**

***Contact 1:***

- **Name:** Site 0115

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Local Institution - 0115

**State:** Midlothian

**Zip:** EH4 2XU

**Location 65:**

**City:** Nottingham

**Contacts:**

***Contact 1:***

- **Name:** Site 0105

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Local Institution - 0105

**Zip:** NG5 1PB

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** See plan description

**Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** See plan description

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** BMS Clinical Trial Patient Recruiting

**URL:** https://www.BMSStudyConnect.com

## 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

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### 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: M11221

- Name: Lymphoma, Follicular

- Relevance: HIGH

- As Found: Lymphoma, Follicular

- 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: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T2361

- Name: Follicular Lymphoma

- Relevance: HIGH

- As Found: Follicular lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000008224

- Term: Lymphoma, Follicular

### Intervention Browse Module - Ancestors

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000018906

- Term: Antineoplastic Agents, Alkylating

- ID: D000000477

- Term: Alkylating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019653

- Term: Myeloablative Agonists

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000903

- Term: Antibiotics, Antineoplastic

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

### Intervention Browse Module - Browse Leaves

- ID: M6727

- Name: Cyclophosphamide

- Relevance: HIGH

- As Found: Cycle

- ID: M7492

- Name: Doxorubicin

- Relevance: HIGH

- As Found: Women

- ID: M227339

- Name: Liposomal doxorubicin

- Relevance: HIGH

- As Found: Women

- ID: M14121

- Name: Prednisone

- Relevance: HIGH

- As Found: Min

- ID: M430

- Name: Bendamustine Hydrochloride

- Relevance: HIGH

- As Found: Dressing

- ID: M373

- Name: Rituximab

- Relevance: HIGH

- As Found: Healthy

- ID: M17495

- Name: Vincristine

- Relevance: HIGH

- As Found: Volume

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20942

- Name: Antineoplastic Agents, Alkylating

- Relevance: LOW

- As Found: Unknown

- ID: M3820

- Name: Alkylating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000011241

- Term: Prednisone

- ID: D000003520

- Term: Cyclophosphamide

- ID: D000069461

- Term: Bendamustine Hydrochloride

- ID: D000069283

- Term: Rituximab

- ID: D000004317

- Term: Doxorubicin

- ID: C000506643

- Term: Liposomal doxorubicin

- ID: D000014750

- Term: Vincristine

### Misc Info Module

- Version Holder: 2024-05-31
