## Protocol Section
### Identification Module
**NCT ID:** NCT03806179

**Acronym:** LYMRIT-37-07

**Brief Title:** Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL

**Official Title:** A Phase 1b Open-label Study of Betalutin in Combination With Rituximab in Patients With Relapsed/Refractory Follicular Lymphoma (Archer-1)

#### Organization Study ID Info
**ID:** LYMRIT -37-07(Archer-1)
#### Organization
**Class:** INDUSTRY
**Full Name:** Nordic Nanovector
#### Secondary ID Infos
**Domain:** EudraCT
**ID:** 2017-004506-18
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-08-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-08-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-12-22

**Type:** ACTUAL

**Results First Submit Date:** 2023-01-15

**Results First Submit QC Date:** 2023-12-21

#### Start Date
**Date:** 2018-10-04

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2019-01-16
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-14
**Study First Submit QC Date:** 2019-01-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** ICON Clinical Research

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Nordic Nanovector

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin in combination with rituximab.

### Conditions Module

**Conditions:**

- Non Hodgkin Lymphoma

- Follicular Lymphoma

- Relapsed Follicular Lymphoma

**Keywords:**

- Radioimmunotherapy

- Lu-177

- Betalutin

- Phase 1b

- Combination

- Rituximab

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

**Intervention Names:**

- Drug: 10 MBq/kg Betalutin

**Label:** 10 MBq/kg Betalutin with rituximab treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

**Intervention Names:**

- Drug: 15 MBq/kg Betalutin

**Label:** 15 MBq/kg Betalutin with rituximab treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 10 MBq/kg Betalutin with rituximab treatment

**Description:** 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

**Name:** 10 MBq/kg Betalutin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 15 MBq/kg Betalutin with rituximab treatment

**Description:** 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

**Name:** 15 MBq/kg Betalutin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin

**Measure:** Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03)

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** Best overall response of combination treatment using tumour responses based on CT and PET/CT imaging (classified as as complete response, partial response, no response/stable disease or progressive disease as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification")

**Measure:** Preliminary Anti-tumour Activity

**Time Frame:** 25 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient must be ≥18 years at the time of signing the informed consent
* ECOG performance status of 0-2
* Histologically confirmed diagnosis (by 2008 World Health Organization \[WHO\] classification) of follicular lymphoma (grade 1, 2 or 3a)
* At least one (but not more than 3) prior regimens with an anti-CD20 antibody (alone or in combination with chemotherapy), with documented relapsed, refractory disease (must not be anti-CD20 antibody-refractory) or PD
* Presence of at least one bi-dimensionally measurable lesion by CT or MRI: longest diameter (LDi) \>1.5 cm for a nodal lesion; LDi \>1.0 cm for an extranodal lesion within 28 days prior to start of treatment
* Normal organ and bone marrow function defined as:

  1. Absolute neutrophil count ≥1.5 x 109/L;
  2. Platelet count ≥150 x 109/L;
  3. Haemoglobin ≥9 g/dL;
  4. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome \[\<3.0 mg/dL\]);
  5. Aspartate transaminase (AST); Alanine transaminase (ALT) or Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN if liver involvement by primary disease);
  6. Adequate renal function as demonstrated by a serum creatinine within the upper limit of normal range
* Bone marrow involvement by lymphoma \<25%
* Life expectancy \>3 months
* Negative hepatitis B, hepatitis C and human immunodeficiency virus (HIV) screening tests
* Patients must agree to use effective contraception for 12 months following last study drug administration

Exclusion criteria:

* Previous haematopoietic stem cell transplantation (autologous and allogenic)
* Evidence of histological transformation from FL to DLBCL at time of screening.
* Previous total body irradiation
* Chemotherapy, immunotherapy or investigational therapy within 28 days before the start of study drug administration (corticosteroid treatment at doses of ≤20 mg/day, topical or inhaled corticosteroids, granulocyte colony-stimulating factor \[G-CSF\] or granulocyte-macrophage colony-stimulating factor \[GM CSF\] are permitted up to 2 weeks prior to start of study treatment) or failure to recover from AEs associated with prior treatment
* Previous treatment with radioimmunotherapy
* Patients who are receiving any other investigational medicinal products
* Known or suspected central nervous system (CNS) involvement of lymphoma
* History of a previous treated cancer except for the following:

  1. adequately treated local basal cell or squamous cell carcinoma of the skin
  2. cervical carcinoma in situ
  3. superficial bladder cancer or localised prostate cancer undergoing surveillance or surgery
  4. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy
  5. other adequately treated Stage 1 or 2 cancer currently in CR
* Pregnant or lactating women
* Exposure to another CD37 targeting drug
* A known hypersensitivity to RTX, lilotomab, Betalutin or murine proteins or any excipient used in RTX, lilotomab or Betalutin
* Receipt of live, attenuated vaccine within 30 days prior to enrolment
* Evidence of severe or uncontrolled systemic diseases (e.g. ongoing infection, respiratory, cardiac, hepatic or psychiatric conditions) which in the Investigator's opinion would compromise the protocol objectives

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ostrava-

**Country:** Czechia

**Facility:** Klinika Hematoonkologie

**State:** Porubá

**Zip:** 807-52

**Location 2:**

**City:** Oslo

**Country:** Norway

**Facility:** Oslo University Hospital

**Zip:** N-0310

#### Overall Officials

**Official 1:**

**Affiliation:** Oslo University Hospital

**Name:** Alexander Fosså, MD.PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Repetto-Llamazares AHV, Malenge MM, O'Shea A, Eiriksdottir B, Stokke T, Larsen RH, Dahle J. Combination of 177 Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin's lymphoma. Eur J Haematol. 2018 Oct;101(4):522-531. doi: 10.1111/ejh.13139. Epub 2018 Aug 31.

**PMID:** 29993152

**Citation:** Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

**PMID:** 25113753

#### See Also Links

**Label:** Sponsor home page

**URL:** http://www.nordicnanovector.com

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-10-04

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 13078903

- Type Abbrev: Prot_SAP

- Upload Date: 2023-12-11T08:23

## 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: Follicular 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: 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 - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M373

- Name: Rituximab

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Removed Countries

- Country: Poland

- Country: United Kingdom

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Treatment emergent AEs from the first dose of rituximab are presented. Under protocol Versions 1 to 3, it was planned to collect treatment-related AEs for the duration of the follow-up period, up to 5 years. This period was removed under protocol Version 4; only the first two participants had entered the follow-up period at the time this version was approved, therefore only these two participants had treatment-related AEs collected up to 36 months before follow-up was closed.

#### Event Groups

**Group ID:** EG000

**Title:** 10 MBq/kg Betalutin With Rituximab Treatment

**Deaths Num At Risk:** 4

**Description:** 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

**ID:** EG000

**Other Num Affected:** 4

**Other Num at Risk:** 4

**Serious Number Affected:** 3

**Serious Number At Risk:** 4

**Title:** 10 MBq/kg Betalutin With Rituximab Treatment

**Group ID:** EG001

**Title:** 15 MBq/kg Betalutin With Rituximab Treatment

**Deaths Num At Risk:** 3

**Description:** 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

**ID:** EG001

**Other Num Affected:** 3

**Other Num at Risk:** 3

**Serious Number At Risk:** 3

**Title:** 15 MBq/kg Betalutin With Rituximab Treatment

**Frequency Threshold:** 0

#### Other Events

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Facial pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Influenza-like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Erysipelas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Rash pustular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Muscle spasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Restless leg syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Night sweats

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Rash erythematous

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Primary progressive aphasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Nerve degeneration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Axillary pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Hyperhidrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Tremor

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Post-traumatic headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Concussion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Wound

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (Unspecified)

**Term:** Hypoaesthesia oral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (Unspecified)

#### Serious Events

**Term:** Erysipelas

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Occurred \>92 days (12 weeks) after Betalutin injection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (Unspecified)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 4

**Group ID:** EG001

**Num At Risk:** 3

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Occurred \>92 days (12 weeks) after Betalutin injection

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

**Source Vocabulary:** MedDRA (Unspecified)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 4

**Group ID:** EG001

**Num At Risk:** 3

**Term:** Bronchitis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Occurred \>92 days (12 weeks) after Betalutin injection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (Unspecified)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 4

**Group ID:** EG001

**Num At Risk:** 3

**Time Frame:** All adverse events (AEs) were collected from the time of informed consent until 4 weeks after the last rituximab dose, up to 25 months. Thereafter treatment related AEs were collected up to 36 months for the first two participants only.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 4

**Group ID:** BG001

**Value:** 3

**Group ID:** BG002

**Value:** 7

**Units:** Participants

### Group

**ID:** BG000

**Title:** 10 MBq/kg Betalutin With Rituximab Treatment

**Description:** 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

### Group

**ID:** BG001

**Title:** 15 MBq/kg Betalutin With Rituximab Treatment

**Description:** 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 6

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 7

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

**Class Title:** Norway

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Czechia

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Whilst the protocol makes reference to a separate statistical analysis plan, given that only seven participants were enrolled and the originally planned expansion phase in a further 20-25 participants was not performed (removed under protocol Version 4.0) a separate detailed statistical analysis plan was not generated.
### Point of Contact
**Email:** mail@nordicnanovector.com
**Organization:** Nordic Nanovector
**Phone:** +47 22 18 33 01
**Title:** Head of Clinical Operations
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** Complete response
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Partial response
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Safety and tolerability of Betalutin in combination with rituximab as determined by the frequency and severity of adverse events (CTCAE v4.03) in the first 12 weeks after Betalutin
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
**ID:** OG000
**Title:** 10 MBq/kg Betalutin With Rituximab Treatment
##### Group
**Description:** 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
**ID:** OG001
**Title:** 15 MBq/kg Betalutin With Rituximab Treatment
#### Outcome Measure 2
**Description:** Best overall response of combination treatment using tumour responses based on CT and PET/CT imaging (classified as as complete response, partial response, no response/stable disease or progressive disease as described in "Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification")
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 25 months
**Title:** Preliminary Anti-tumour Activity
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
**ID:** OG000
**Title:** 10 MBq/kg Betalutin With Rituximab Treatment
##### Group
**Description:** 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
**ID:** OG001
**Title:** 15 MBq/kg Betalutin With Rituximab Treatment
### Participant Flow Module
#### Group
**Description:** 10 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

10 MBq/kg Betalutin: 10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
**ID:** FG000
**Title:** 10 MBq/kg Betalutin With Rituximab Treatment
#### Group
**Description:** 15 MBq/kg Betalutin administered with lilotomab pre-dose on day 0; rituximab administered weekly x 4 doses from day 7, then every 3 months for 2 years

15 MBq/kg Betalutin: 15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
**ID:** FG001
**Title:** 15 MBq/kg Betalutin With Rituximab Treatment
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Progressive disease
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Has Results:** True