Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS).

The goal is to obtain a 15% increase of EFS at 2 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Aged 18 to 65 years

• Patients with pathologically proven at relapse, low grade B-cell lymphoma CD20- positive (World Health Organization [WHO] classification):

• Marginal zone;

• Lymphocytic; or

• Follicular.

• In relapse after complete remission (CR), less than partial remission (PR) or partial response (maximum of 3 lines of treatment)

• Previously treated with chemotherapy regimen with or without rituximab

• With a chemo-sensitive disease using salvage therapy

• Eligible for autologous stem cell transplantation

• ECOG performance status 0 to 2

• Minimum life expectancy of 3 months

• Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies < 4 weeks (except after vaccination)

• Signed informed consent form

Exclusion Criteria:

• Histological transformation in diffuse large cell from a low grade B-cell lymphoma

• Prior transplantation

• Contraindication to any drug contained in the chemotherapy regimens

• Large bone marrow irradiation > 40%

• Bone marrow infiltration > 25%

• Lack of sufficient autologous stem cells for transplantation

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study

• Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigational Drug Brochure [IDB])

• Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration

• Poor renal function (creatinine level > 2.5 maximum normal level) unless abnormalities are related to the lymphoma

• Poor hepatic function (total bilirubin level > 30 mmol/l, transaminases > 2.5 maximum normal level) unless abnormalities are related to the lymphoma

• Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma

• Presence of anti-murine antibody (HAMA) reactivity

• Known hypersensitivity to murine antibodies or proteins

• Pregnant women

• Adult patients unable to give informed consent because of intellectual impairment