Treatment of lymphoma with targeted internal radiation therapy(Betalutin)

Phase 1

• Conditions: on-Hodgkin B-cell lymphoma; MedDRA version: 18.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000033-36-ES
• Lead Sponsor: ordic Nanovector ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-18
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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. Measurable disease by radiological methods.
7. Women of childbearing potential must:
a) understand that the study medication is expected to have teratogenic risk.
b) have a negative pregnancy test.
c) 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 12 months after end of study drug therapy, even if she has amenorrhoea.
8. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
9. Patients previously treated with native rituximab are eligible.
10. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
11. The patient has been fully informed about the study and has signed the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

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:
a. Absolute Neutrophil Counts (ANC) ? 1.5 x 109 /l.
b. Platelet count ? 150 x 109 /l.
c. Total bilirubin ? 30 mmol/l.
d. ALP and ALAT ? 4x normal level.
e. Creatinine ? 115 µmol/l (men), 97 µmol/l (women).
f. 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. Pre-treatment with rituximab is allowed.
7. Pregnant or lactating women.
8. Previous hematopoietic stem cell transplantation (autologous and allogenic).
9. Previous treatment with radioimmunotherapy.
10. Actively participating in another study or received an investigational drug within 4 weeks prior to enrolment.
11. Receipt of live, attenuated vaccine within 30 days prior to enrolment.
12. Test positive for hepatitis B (HBsAg and anti-HBc).
13. A known hypersensitivity to rituximab, HH1, Betalutin or murine proteins or any excipient used in rituximab, HH1 or Betalutin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified