Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Lymphoma Study Association
• Treatments: Fludarabine; Fludarabine phosphate; Mitoxantrone; Rituximab; Vidarabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.