A Phase I/II Trial of VR-CHOP in Lymphoma Patients

This study is currently recruiting participants.
Verified March 2012 by Emory University

First Received on February 11, 2008.  
Last Updated on March 15, 2012  
History of Changes
This Clinical Trial Sponsored By: Emory University
Collaborator: Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party): Christopher R. Flowers, Emory University
ClinicalTrials.gov Identifier: NCT00634179
 

Purpose for Clinical Trial

This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial, which is now continuing to enroll patients in the phase 2 portion of the trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin’s lymphomas (NHL).

Condition Study Intervention Phase
Lymphoma, B-Cell
Follicular Lymphoma
Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, bortezomib, prednisone Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Rituximab
Bortezomib

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures For Clinical Trial:

  • To identify the maximal tolerated doses of bortezomib and vincristine when used in combination of bortezomib, rituximab and the CHOP chemotherapy regimen [ Time Frame: Cycle 1 for MTD, following completion of therapy for CR ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • An estimate of the overall response rate (ORR)(complete response [CR] + CR unconfirmed [CRu] + partial response [PR] to VR-CHOP according to IWRC criteria [ Time Frame: Following completion of therapy ] [ Designated as safety issue: No ]

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 Study 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 the VR-CHOP regimen. In phase 2, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP. At the start of phase 1, treatment consisted 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 occured in phase 1 to a maximum bortezomib dose of 1.6 mg/m2 given on days 1 and 8. The phase 1 portion of the trial determined that patients enrolled in phase 2 should start treatment at a bortezomib dose of 1.6 mg/m2 given on days 1 and 8 and a vincristine dose of 1.4 mg/m2 (capped at 1.5 mg).
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 1.6 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

Detailed Description:

This study will assess whether adding bortezomib (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 receive VR-CHOP at the doses of Velcade and vincristine established in phase 1. 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. All patients will go on to receive maintenance therapy after completion of their initial treatment as designed by the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Tissue diagnosis of a previously untreated, CD20+, B-Cell Non-Hodgkin Lymphoma.

For the Phase 1 trial: Patients with any of the following diagnoses are eligible:

  • Follicular Lymphomas (Grade 1, 2, 3a, 3b)
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphomas

For the Phase 2 trial: Patients with any of the following diagnoses are eligible:

  • Follicular Lymphomas (Grade 1, 2, 3a)
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphomas
  • Patients with follicular or other low-grade lymphoma must have an indication for treatment based on modified GELF criteria or a FLIPI score ≥3
  • Indications for treatment based on modified GELF criteria include any one of the following:
  • B symptoms or other lymphoma-related symptoms
  • Involvement of 3 nodal sites, each with a diameter of 3 cm
  • Any nodal or extranodal tumor mass with a diameter of 7 cm
  • Splenomegaly
  • Pleural effusions or peritoneal ascites
  • Cytopenias (leukocytes < 1.0 x 10 /L and/or platelets < 100 x 10 /L)
  • Leukemia (> 5.0 x 10 /L circulating malignant cells)
  • Indications for treatment based on FLIPI criteria include any three of the following:
  • Age &#

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