Follicular Lymphoma Clinical Trial
Official title:
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.
Verified date | August 2019 |
Source | Lymphoma Study Association |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Service de médecine D - Maladies du Sang CHU Angers | Angers | |
France | Service d'Hématologie Hôpital Jean Minjoz | Besançon | |
France | Hôpital Henri Mondor | Créteil | |
France | Hôpital A. Michallon BP 217X | Grenoble | |
France | Service Oncologie - Centre Victor Hugo | Le Mans | |
France | Service d'hématologie clinique - Centre Hospitalier du Dr Schaffner | Lens | |
France | Hôpital Claude Huriez - Sce des Maladies du Sang - Place Verdun | Lille | |
France | Centre Hospitalier Lyon-sud | Lyon | |
France | Centre régional de lutte contre le cancer Léon Bérard | Lyon | |
France | Service d'hématologie Institut Paoli Calmette | Marseille | |
France | Service d'hématologie - Hôpital Necker | Paris | |
France | Service d'Hématologie Hôpital St Louis | Paris | |
France | Service d'hématologie clinique - Hôpital de Pontchaillou | Rennes | |
France | Centre Henri Becquerel | Rouen | |
France | Service Oncologie CHU Bretonneau | Tours | |
France | Service d'hématologie Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Lymphoma Study Association |
France,
Horning SJ. Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol. 1993 Oct;20(5 Suppl 5):75-88. Review. — View Citation
Maloney DG, Grillo-López AJ, White CA, Bodkin D, Schilder RJ, Neidhart JA, Janakiraman N, Foon KA, Liles TM, Dallaire BK, Wey K, Royston I, Davis T, Levy R. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood. 1997 Sep 15;90(6):2188-95. — View Citation
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 92:41
McLaughlin P, Hagemeister FB, Romaguera JE, Sarris AH, Pate O, Younes A, Swan F, Keating M, Cabanillas F. Fludarabine, mitoxantrone, and dexamethasone: an effective new regimen for indolent lymphoma. J Clin Oncol. 1996 Apr;14(4):1262-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | to evaluate progression free survival after a combination of rituximab, fludarabine and mitoxantrone (RFM) in patients with relapsed or primary failing advanced follicular non-Hodgkin's lymphoma. | 2 years | ||
Secondary | overall response rate (ORR) | 5 years | ||
Secondary | complete response (CR) | 5 years | ||
Secondary | to evaluate overall survival (OS) | 5 years | ||
Secondary | duration of response | 5 years | ||
Secondary | number of Serious Adverse Event (SAE) | 5 years | ||
Secondary | to monitor minimal residual disease using the molecular biological marker bcl2 in peripheral blood and bone marrow | 5 years |
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