Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
- Conditions
- Follicular Lymphoma
- Interventions
- Registration Number
- NCT00850499
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief Summary
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- Male or female subjects 18 years or older
- Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
- Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
- Documented relapse or progression following last antineoplastic treatment
- At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
-
Subjects with histological or clinical transformation to an aggressive lymphoma
- prior treatment with VELCADE or fludarabine.
- antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
- nitrosoureas within 6 weeks before randomization
- radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
- major surgery within 3 weeks before randomization
- chronic use of corticosteroids, such as dexamethasone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VELCADE and fludarabine (Group A) VELCADE VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle fludarabine and rituximab (Group B) fludarabine fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle fludarabine and rituximab (Group B) rituximab fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle VELCADE and fludarabine (Group A) fludarabine VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
- Primary Outcome Measures
Name Time Method Complete Response Rate Up to 8 cycles (1 cycle is 35 days: 280 days) The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
- Secondary Outcome Measures
Name Time Method Overall Response Rate Up to 8 cycles (1 cycle is 35 days: 280 days) The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.
Trial Locations
- Locations (43)
CHU d'Amiens
🇫🇷Amiens, 80, France
Institut Bergonie
🇫🇷Bordeaux, 33, France
CHU Hotel Dieu
🇫🇷Clermont Ferrand, 63, France
Centre Victor Hugo
🇫🇷Le Mans, 72, France
CHU Caremeau
🇫🇷Nimes, 30, France
Hoptial Saint Louis
🇫🇷Paris Cedex 10, 75, France
Hopital Cochin
🇫🇷Paris, 75, Cedex 14, France
Klinikum Bamberg, fachbereich 3
🇩🇪Bamberg, Germany
Vivantes Klinikum am Urban
🇩🇪Berlin, BE, Germany
Charite, group Benjamin Franklin
🇩🇪Berlin, Germany
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