Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00581776|
Recruitment Status : Completed
First Posted : December 28, 2007
Results First Posted : February 15, 2011
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma|
|Study Start Date :||May 2005|
|Primary Completion Date :||November 2012|
|Study Completion Date :||May 2015|
Experimental: VCR-CVAD with rituximab maintenance
Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years.
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
Other Name: Velcade, PS-341Drug: Rituximab
Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
Other Name: RituxanDrug: Cyclophosphamide
Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
Other Name: cytoxanDrug: Doxorubicin
Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.Drug: Vincristine
1 mg administered by IV on day 3 of each cycle.Drug: Dexamethasone
40 mg orally on days 1-4 of each cycle.
- Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). [ Time Frame: At completion of induction therapy (21 weeks) ]
Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.
1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses.
- Complete Response Rate (CR) at the End of Induction Chemotherapy [ Time Frame: at 21 weeks ]Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.
- 3 Year Progression Free Survival [ Time Frame: 36 months ]This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.
- 3 Year Overall Survival (OS) [ Time Frame: 36 months ]This is the percent of participants who were still alive at 3 years after study entry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581776
|United States, Wisconsin|
|University Of Wisconsin Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Brad S Kahl, MD||University of Wisconsin, Madison|