Status:
COMPLETED
Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
Lymphoma Study Association
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin's lymphoma (NHL).
Detailed Description
Follicular non Hodgkin's lymphoma's (FL), as defined by the Revised European American Lymphoma Classification (REAL) Classification, are usually characterized by a slowly progressive clinical course, ...
Eligibility Criteria
Inclusion
- 18 years \< age \< 75 years
- Pathologically confirmed low grade, follicular, B cell lymphoma (WHO Classification Follicular grades 1 and 2
- Failed at least first line chemotherapy with any standard anthracycline containing regimen (see appendix C for definition of treatment failure)
- Frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
- The lymphoma must be CD20 positive (on the biopsy material obtained at relapse or disease progression)
- At least one measurable lesion one nodal or extranodal lesion
- WHO performance status grade 0 or 1
- Bulky disease at study entry according to the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria: Nodal or extranodal single mass \> 7cm in its greatest diameter; systemic B-symptoms; increased lactate dehydrogenase (LDH) and beta 2 macroglobulinemia (\> 3mg/L); involvement of at least 3 nodal sites, each with a diameter of greater than 3 cm; splenic enlargement with margin below the umbilical line or cranio caudal diameter of greater than 20 cm; compression syndrome (ureteral, orbital, gastrointestinal), or pleural or peritoneal serous effusion.
- Patient information and written informed consent
Exclusion
- Evidence of histological transformation to diffuse large B-cell lymphoma
- \> 2 prior treatment regimen
- Chemotherapy, or other experimental anticancer treatment during the 4 weeks before inclusion
- Any radiation therapy to the index lesion(s) during the 4 weeks before inclusion
- Autologous stem cell transplant during the 3 months before inclusion
- Prior treatment including fludarabine and / or mitoxantrone and / or rituximab or contra-indication to one of these products
- Unless exempted by the Responsible Investigator, as lymphoma related: serum creatinine \>2 x Institutional Upper Limit of Normal (IULN), total bilirubin \>2 x IULN or aspartate aminotransferase (AST) \>2 x IULN, alkaline phosphatase \>2 x IULN
- Low bone marrow function: absolute neutrophil count \< 1500/mm3 and platelet \< 100 x 109/L at study entry (unless bone marrow infiltration)
- Clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
- Evidence of symptomatic central nervous system disease
- Known positivity for HIV, hepatitis Bs antigen or hepatitis C
- Pregnant or lactating women. Women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 6 months after cessation of therapy
- Patients considered for an autologous or allogenic stem transplant at time of primary treatment failure or relapse according to the rules of the respective centers
- Any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
- Previous evolutive malignancy within 5 years of study entry, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- Major surgery within 4 weeks prior to enrollment, unless patient has recovered from all treatment related toxicity
- Patient under tutelage.
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00169208
Start Date
April 1 2001
End Date
December 1 2006
Last Update
August 28 2019
Active Locations (16)
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1
Service de médecine D - Maladies du Sang CHU Angers
Angers, France, 49033
2
Service d'Hématologie Hôpital Jean Minjoz
Besançon, France, 25030
3
Hôpital Henri Mondor
Créteil, France, 94010
4
Hôpital A. Michallon BP 217X
Grenoble, France, 38043