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| Sponsor: | Emory University |
|---|---|
| Collaborator: |
Millennium Pharmaceuticals, Inc. |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00634179 |
Purpose
This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, B-Cell Follicular Lymphoma |
Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, bortezomib, prednisone |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas |
| Estimated Enrollment: | 39 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
This is an open-label, single-center, prospective phase 1/2 clinical trial with a dose escalation and de-escalation schema for bortezomib and vincristine to identify the maximum tolerated doses (MTD) of bortezomib and vincristine when used in a chemotherapy regimen consisting of VELCADE and R-CHOP.In phase 2, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects. At the start of phase 1, treatment will consist of rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 given on day 1, bortezomib 1.3 mg/m2 given on days 1 and 8, and prednisone 100 mg/day given orally on days 1-5. Dose titration will occur in the phase 1 portion to a maximum bortezomib dose of 1.6 mg/m2 given on days 1 and 8 followed by titration of the vincristine dose to 1.4 mg/m2.
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Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, bortezomib, prednisone
rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 (capped at 1.5 mg maximum) given on day 1, bortezomib 1.3 mg/m2 given on days 1 and 8, and prednisone 100 mg/day given orally on days 1-5.
Other Name: Velcade, R-CHOP, VR-CHOP, BR-CHOP,CHOP-R
|
This study will assess whether adding Velcade to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment.
Patients who are eligible to take part in the study will initially receive VR-CHOP with an increase in the dose of Velcade and then the dose of vincristine to determine the safe doses for these drugs in combination. Then, patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Georgia | |
| Emory University Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Christopher Flowers, MD, MS 888-946-7447 | |
| Principal Investigator: Christopher Flowers, MD | |
| Principal Investigator: | Christopher Flowers, MD | Emory University |
More Information
| Responsible Party: | Christopher Flowers, MD, Winship Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00634179 History of Changes |
| Other Study ID Numbers: | IRB# 29960007 |
| Study First Received: | February 11, 2008 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Lymphoma |
|
Lymphoma Lymphoma, Follicular Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Bortezomib Doxorubicin Prednisone |
Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones |