Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)

January 8, 2019 updated by: Nordic Nanovector

A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma

This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Germany
      • Würzburg, Germany
        • Universitatsklinikum Wurzburg

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed (by WHO classification) relapsed indolent non-Hodgkin B-cell lymphoma of following subtypes: Follicular lymphoma (follicular grade I-IIIA), Marginal zone lymphoma (exclusion of MZL if large lymphocytes > 50%), Small lymphocytic lymphoma, Lymphoplasmacytoid and classical mantle cell lymphoma (no blastoid MCL).
  2. Requiring initiation of treatment for the NHL.
  3. Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
  4. Exhausted and/or ineligible for all standard treatment options.
  5. Not a candidate for an autologous or allogeneic stem cell transplantation. Patients in progression after successful stem cell collection before before high-dose therapy and autologous stem cell transplantation may be considered for enrolment.
  6. Age ≥ 18 years..
  7. A pre-study ECOG performance status of 0-2. In selected patients an ECOG score of 3 can be acceptable if it is clearly lymphoma-associated at the discretion of the investigator.
  8. Life expectancy should be ≥ 3 months.
  9. 9. < 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment (biopsy taken from a site not previously irradiated).
  10. All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan). Patients without such a target lesion can be accepted on an individual basis if histological organ involvement can be evaluated for response e.g. involvement of the skin or the gastrointestinal tract.

  11. Women of childbearing potential must:

    • have a negative serum pregnancy test at screening and before Betalutin injection
    • understand that the study medication is expected to have teratogenic risk
    • agree to use, and be able to comply with, highly effective method of birth control with a Pearl-Index ≤ 1%. Contraception is required without interruption, 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea.
  12. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
  13. Patients previously treated with native rituximab are eligible.
  14. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
  15. The patient has been fully informed about the study and has signed the informed consent form.
  16. Negative HAMA test.
  17. CD37 positive, re-biopsy or test on existing tumour material if not known

Exclusion Criteria:

  1. Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.

  2. Laboratory values during screening :

    • Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l
    • Platelet count ≤ 150 x 109 /l
    • Total bilirubin ≥ 30 mmol/l
    • ALP and ALAT ≥ 4x normal level
    • GFR < 60 ml/min/1.73 m2 as measured by the CKD-EPI method.
  3. Known or suspected CNS involvement of lymphoma
  4. Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.
  5. Chemotherapy, immunotherapy or another investigational drug received within the last 4 weeks prior to the patient entering screening.
  6. Earlier treatment with radioimmunotherapy.
  7. Exposure to another CD37 targeting drug.
  8. Concurrent participation in another therapeutic treatment trial.
  9. Previous hematopoietic stem cell transplantation (autologous and allogenic).
  10. Pregnant or lactating women.
  11. Transformed or potentially transformed NHL from indolent to aggressive
  12. Receipt of live, attenuated vaccine within 30 days prior to enrolment
  13. Test positive for hepatitis B (HBsAg and anti-HBc)
  14. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin
  15. Malignant disease, other than that being treated in this study. Exceptions include: malignancies that were treated curatively and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancers; completely resected carcinoma in situ of any type.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Betalutin with lilotomab dose 1
Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing
Drug: Betalutin with lilotomab dose 1
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1
Other Names:
  • Betalutin
  • Lymrit 37-02
  • lutetium (177Lu) lilotomab satetraxetan
  • HH1
  • 177Lu-DOTA-HH1
Experimental: Arm 2: Betalutin with lilotomab dose 2
Betalutin 15MBq/kg b.w. with lilotomab pre-dosing
Drug: Betalutin with lilotomab dose 2
15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2
Other Names:
  • Betalutin
  • Lymrit 37-02
  • lutetium (177Lu) lilotomab satetraxetan
  • HH1
  • 177Lu-DOTA-HH1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry
Time Frame: 3 weeks
Estimation of individual tumour/organ uptake and retention of radioactivity.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants with adverse events as assessed by NCTCAE.
Time Frame: 12 weeks
Adverse events by treatment group.
12 weeks
Efficacy (Best overall response rate)
Time Frame: 3 months - 1 year
Best overall response rate by treatment group as measured by Cheson Criteria.
3 months - 1 year
Lilotomab pharmacokinetics
Time Frame: 3 weeks
Estimation using decay correction measurements
3 weeks

Collaborators and Investigators

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

Sponsor

Nordic Nanovector

Investigators

  • Principal Investigator: Andreas Buck, Prof. MD, Wuerzburg 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

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)

December 19, 2017

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT: 2013-003908-39

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

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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