Status and phase
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About
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.
Sex
Ages
Volunteers
Inclusion criteria
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).
Requiring initiation of treatment for the NHL.
Relapsed after at least one line of therapy including rituximab combination chemotherapy regimen.
Exhausted and/or ineligible for all standard treatment options.
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.
Age ≥ 18 years..
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.
Life expectancy should be ≥ 3 months.
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.
Women of childbearing potential must:
Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
Patients previously treated with native rituximab are eligible.
The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
The patient has been fully informed about the study and has signed the informed consent form.
Negative HAMA test.
CD37 positive, re-biopsy or test on existing tumour material if not known
Exclusion criteria
Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, steroid requiring asthma/allergy, known HIV positive.
Laboratory values during screening :
Known or suspected CNS involvement of lymphoma
Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow.
Chemotherapy, immunotherapy or another investigational drug received within the last 4 weeks prior to the patient entering screening.
Earlier treatment with radioimmunotherapy.
Exposure to another CD37 targeting drug.
Concurrent participation in another therapeutic treatment trial.
Previous hematopoietic stem cell transplantation (autologous and allogenic).
Pregnant or lactating women.
Transformed or potentially transformed NHL from indolent to aggressive
Receipt of live, attenuated vaccine within 30 days prior to enrolment
Test positive for hepatitis B (HBsAg and anti-HBc)
A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin
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.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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