A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma
Conditions
Non-Hodgkin Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
Radioimmunotherapy, Lu-177, Phase I study, Phase II study, Betalutin
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Betalutin
Type: Drug
Overall Status
Recruiting
Summary
This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma. The Phase I part of the study is a dose escalating study to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. After completion of the phase I study, a dose will be selected for the phase II part of the study which is designed to investigate tumour response rate, progression free survival, confirmation of the selected dose as well as safety and toxicity.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Histologically confirmed (by WHO classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA, marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.

2. Age ≥ 18 years

3. A pre-study WHO performance status of 0-1

4. Life expectancy should be ≥ 3 months

5. <25% tumour cells in bone marrow biopsy

6. CD37+, re-biopsy or test on existing tumour material if not known.

7. Measurable disease by radiological methods

8. Women of childbearing potential must:

1. understand that the study medication is expected to have teratogenic risk

2. have a negative pregnancy test

3. agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy and for 5 months after end of study drug therapy, even if she has amenorrhoea

9. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 5months

10. Patients previously treated with native rituximab are eligible

11. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination

12. The patient has been fully informed about the study and has signed the informed consent form

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 within 15 days pre-registration:

1. Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l

2. Platelet count ≤ 150 x 109 /l

3. Total bilirubin ≥ 30 mmol/l

4. ALP and ALAT ≥ 4x normal level)

5. Creatinine ≥ 110 µmol/l (men), 90 µmol/l (women))

6. IgG ≤ 3 gr/l

3. Known CNS involvement of lymphoma

4. Previous total body irradiation, or irradiation of > 25% of the patient's bone marrow

5. Known history of HAMA

6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pretreatment with rituximab is allowed.

7. Pregnant or lactating women
Locations
Oslo University Hospital
Oslo, Norway
Status: Recruiting
Contact: Arne Kolstad, MD - +47 22934000 - ARNEK@ous-hf.no
St. Olavs hospital
Trondheim, Norway
Status: Recruiting
Contact: Unn-Merete Fagerli, Senior consultant - Unn.Merete.Fagerli@stolav.no
Norrlands University Hospital
Umeå, Sweden
Status: Recruiting
Contact: Martin Erlanson, MD - martin.erlanson@onkologi.umu.se
Start Date
December 2012
Completion Date
March 2018
Sponsors
Nordic Nanovector
Source
Nordic Nanovector
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page