Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT00581776 |
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Recruitment Status :
Completed
First Posted : December 28, 2007
Results First Posted : February 15, 2011
Last Update Posted : December 17, 2019
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Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
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Brief Summary:
Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mantle Cell Lymphoma | Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone | Phase 2 |
Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | May 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Bortezomib
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
Other Name: Velcade, PS-341 Drug: 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: Rituxan Drug: 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: cytoxan Drug: 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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.
Exclusion Criteria:
- Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.
Information from the National Library of Medicine
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
Locations
| United States, Wisconsin | |
| University Of Wisconsin Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Brad S Kahl, MD | University of Wisconsin, Madison |
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00581776 |
| Other Study ID Numbers: |
HO05401 2011-0807 ( Other Identifier: Institutional Review Board ) A534260 ( Other Identifier: UW Madison ) SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison ) |
| First Posted: | December 28, 2007 Key Record Dates |
| Results First Posted: | February 15, 2011 |
| Last Update Posted: | December 17, 2019 |
| Last Verified: | May 2016 |
Keywords provided by University of Wisconsin, Madison:
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Untreated Mantle Cell Lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Dexamethasone Cyclophosphamide Rituximab Doxorubicin Vincristine Bortezomib |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Glucocorticoids |