Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma
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An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-Tumor Activity and Safety of a Combination of Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma.
Study Start Date :
Study Completion Date :
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 GELF criteria: Nodal or extranodal single mass > 7cm in its greatest diameter; systemic B-symptoms; increased LDH and beta 2 microglobulinemia (> 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
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 AST (SGOT) >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 CNS disease
Known positivity for HIV, HBs 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
McLaughlin P, Grillo-Lopez AJ, Maloney DG, Link BK, Levy R, Czuczman MS, Cabanillas F, Dallaire BK, White CA: Efficacy controls and long-term follow-up of patients treated with rituximab for relapsed or refractory, low-grade or follicular NHL. Blood 92:414a, 1998