Status:
COMPLETED
Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Conditions:
B-Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 (EF...
Detailed Description
The indolent course of the low-grade B-cell lymphoma is thus characterized by multiple remissions and relapses with ever-shortening "time to progression" intervals, and by ultimately becoming refracto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2009
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00138086
Start Date
March 1 2005
End Date
March 1 2009
Last Update
September 8 2006
Active Locations (9)
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1
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
2
Hôpital Henri Mondor
Créteil, France, 94010
3
Hématologie CHU de Lille
Lille, France, 59000
4
Institut Curie
Paris, France, 75005