Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma
B-Cell Lymphoma
About this trial
This is an interventional treatment trial for B-Cell Lymphoma focused on measuring lymphoma, chemotherapy, Zevalin ( Yttrium-90 Ibritumomab Tiuxetan)
Eligibility 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
Sites / Locations
- Groupe d'Etude des Lymphomes de l'adulte
- Hôpital Henri Mondor
- Hématologie CHU de Lille
- Institut Curie
- Hôpital Saint Louis
- Service d'Hématologie - Centre Hospitalier Lyon-Sud
- Centre Henri Becquerel
- Institut Gustave Roussy
- Schweirische Arbeitsgruppe fur klinische Krebsforschung