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Sponsored by: |
Fondazione Intergruppo Italiano Linfomi Onlus |
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Information provided by: | Fondazione Intergruppo Italiano Linfomi Onlus |
ClinicalTrials.gov Identifier: | NCT00774826 |
The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms:
R−CVP vs R−CHOP vs R−FM.
Condition | Intervention | Phase |
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Follicular Lymphoma |
Drug: R-CVP Drug: R-CHOP Drug: R-FM |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Multicentric IIL Study, Three Randomized Arms (R−CVP vs R−CHOP vs R−FM),for Treatment of Patients With Stage II−IV Follicular Lymphoma |
Estimated Enrollment: | 431 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
R-CVP x 3; Restaging if> RP then R-CVP x 5
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Drug: R-CVP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1, Vincristina: 1,4 mg/mq day 1 Prednisone: 40 mg/mq day 1-5,
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2: Experimental
R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab
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Drug: R-CHOP
Rituximab: 375 mg/mq day 1 Ciclofosfamide: 750 mg/mq day 1 Doxorubicina: 50 mg/mq day 1 Vincristina: 1.4 mg/mq day 1 Prednisone: 100 mg/mq day 1-5
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3: Experimental
R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab
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Drug: R-FM
Rituximab: 375 mg/mq day 1, Fludarabina: 25 mg/mq day 1-3, Mitoxantrone: 10 mg/mq day 1,
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Assessment of Overall Survival (OS)in patients treated with R−CVP, R−CHOP and R−FM. −Assessment of Progression Free Survival (PFS)in patients treated with R−CVP, R−CHOP − Assessment of Duration of Response (DR)in patients treated with R−CVP, R−CHOP and R−FM. − Assessment of Response Rate(RR) in patients treated with R−CVP, R−CHOP and R−FM. − Assessment of molecular Response Rate in patients treated with R−CVP, R−CHOP and R−FM. − Assessment of toxicity of R−CVP, R−CHOP, R−FM treatments.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of one of these criteria:
Exclusion Criteria:
Contact: Sonia Perticone, PhD | 00390131206129 | segreteria@iilinf.it |
Principal Investigator: | Massimo Federico, PhD | Azienda Ospedaliera - Universitaria di Modena |
Responsible Party: | AZIENDA OSPEDALIERA POLICLINICO - MODENA (MO) ( MASSIMO FEDERICO ) |
Study ID Numbers: | IIL−FOLL05, Eudract Number 2005−005406−24 |
Study First Received: | October 14, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00774826 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Follicular lymphoma Rituximab |
Prednisone Lymphatic Diseases Immunoproliferative Disorders Rituximab Lymphoma, Follicular Mitoxantrone |
Cyclophosphamide Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |