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Sponsored by: |
Millennium Pharmaceuticals |
Information provided by: | Millennium Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00715208 |
This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, cyclophosphamide, and prednisone (VELCADE-R-CP) based on investigator preference. Following completion of the treatment period, patients will receive maintenance therapy with rituximab up to a maximum of 2 years.
Condition | Intervention | Phase |
Relapsed Follicular Lymphoma |
Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin Drug: VELCADE, rituximab, cyclophosphamide, and prednisone |
Phase II |
MedlinePlus related topics: | Lymphoma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Prednisone Rituximab Bortezomib |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma. |
Estimated Enrollment: | 88 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
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Drug: VELCADE, rituximab, cyclophosphamide, prednisone, and Doxorubicin
VELCADE will be administered as a 3- to 5-second Intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 Intravenous on Day 1, doxorubicin 50 mg/m2 Intravenous on Day 1, VELCADE 1.6 mg/m2 Intravenous on Days 1 and 8, prednisone 100 mg PO on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
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2: Experimental
VELCADE, rituximab, cyclophosphamide, and prednisone
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Drug: VELCADE, rituximab, cyclophosphamide, and prednisone
VELCADE will be administered as a 3- to 5-second Intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 1000 mg/m2 Intravenous on Day 1, VELCADE 1.6 mg/m2 Intravenous on Days 1 and 8, prednisone 100 mg by mouth on Days 1 to 5 of a 21-day (3-week) cycle for 6 cycles.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical laboratory values within 21 days prior to enrollment:
Exclusion Criteria:
Contact: Christine Colby, PharmD | 1-866-835-2233 | medical@mlnm.com |
United States, New York | |||||
Columbia University - Herbert Irving Comprehensive Cancer Center | Recruiting | ||||
New York, New York, United States, 10032 | |||||
Contact: Rachel Hamelers 212-342-3590 rh2340@columbia.edu |
Millennium Pharmaceuticals |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Research Monitor ) |
Study ID Numbers: | C05012 |
First Received: | July 11, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00715208 |
Health Authority: | United States: Food and Drug Administration |
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