Study of Safety and Efficacy of Betalutin and Rituximab in Patients With FL (LYMRIT-37-07)

December 21, 2023 updated by: Nordic Nanovector

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Porubá
      • Ostrava-, Porubá, Czechia, 807-52
        • Klinika Hematoonkologie
  • Norway
      • Oslo, Norway, N-0310
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 MBq/kg Betalutin with rituximab treatment
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
Drug: 10 MBq/kg Betalutin
10 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2
Experimental: 15 MBq/kg Betalutin with rituximab treatment
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
Drug: 15 MBq/kg Betalutin
15 MBq/kg Betalutin, lilotomab 40mg, rituximab 375 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability: Frequency and Severity of Adverse Events (CTCAE v4.03)
Time Frame: 12 weeks
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary Anti-tumour Activity
Time Frame: 25 months
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")
25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Nanovector

Collaborators

ICON Clinical Research

Investigators

  • Principal Investigator: Alexander Fosså, MD.PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2018

Primary Completion (Actual)

August 8, 2022

Study Completion (Actual)

August 8, 2022

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYMRIT -37-07(Archer-1)
  • 2017-004506-18 (Other Identifier: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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