Dosimetry Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-02)
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT02657447
- Lead Sponsor
- Nordic Nanovector
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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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).
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Requiring initiation of treatment for the NHL.
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Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
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Exhausted and/or ineligible for all standard treatment options.
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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.
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Age ≥ 18 years..
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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.
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Life expectancy should be ≥ 3 months.
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- < 25% tumour cells in bone marrow biopsy prior to lilotomab/Betalutin treatment (biopsy taken from a site not previously irradiated).
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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.
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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.
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Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
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Patients previously treated with native rituximab are eligible.
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The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
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The patient has been fully informed about the study and has signed the informed consent form.
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Negative HAMA test.
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CD37 positive, re-biopsy or test on existing tumour material if not known
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Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.
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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.
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Known or suspected CNS involvement of lymphoma
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Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.
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Chemotherapy, immunotherapy or another investigational drug received within the last 4 weeks prior to the patient entering screening.
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Earlier treatment with radioimmunotherapy.
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Exposure to another CD37 targeting drug.
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Concurrent participation in another therapeutic treatment trial.
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Previous hematopoietic stem cell transplantation (autologous and allogenic).
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Pregnant or lactating women.
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Transformed or potentially transformed NHL from indolent to aggressive
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Receipt of live, attenuated vaccine within 30 days prior to enrolment
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Test positive for hepatitis B (HBsAg and anti-HBc)
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A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Betalutin with lilotomab dose 1 Betalutin with lilotomab dose 1 Betalutin 15 MBq/kg b.w. with lilotomab pre-dosing Arm 2: Betalutin with lilotomab dose 2 Betalutin with lilotomab dose 2 Betalutin 15MBq/kg b.w. with lilotomab pre-dosing
- Primary Outcome Measures
Name Time Method Dosimetry 3 weeks Estimation of individual tumour/organ uptake and retention of radioactivity.
- Secondary Outcome Measures
Name Time Method The number of participants with adverse events as assessed by NCTCAE. 12 weeks Adverse events by treatment group.
Lilotomab pharmacokinetics 3 weeks Estimation using decay correction measurements
Efficacy (Best overall response rate) 3 months - 1 year Best overall response rate by treatment group as measured by Cheson Criteria.
Trial Locations
- Locations (1)
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany