Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

This study is ongoing, but not recruiting participants.

First Received on December 29, 2009.  
Last Updated on January 13, 2012  
History of Changes
This Clinical Trial Sponsored By: Millennium Pharmaceuticals, Inc.
Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party): Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01040871
 

Purpose for Clinical Trial

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Clinical Trial Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

Condition Study Intervention Phase
Diffuse Large B-Cell Lymphoma Drug: VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Randomized
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Multicenter Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

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 Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures For Clinical Trial:

  • Complete response (CR) rate [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Overall response rate [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • Duration of CR [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • Time to subsequent anti-lymphoma therapy [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • Estimates of 1- and 2-year progression-free survival (PFS) rates [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • Estimates of 1- and 2-year overall survival rates [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • Safety profile of VR-CAP regimen [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ]
  • Change in fatigue and patient utility scores [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
  • RNA-based signatures that correlate with response to treatment [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: January 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: VR-CAP

VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
Drug: VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone

Rituximab intravenous on Day 1, Cyclophosphamide intravenous on Day 1, Doxorubicin intravenous on Day 1, VELCADE intravenous on Days 1,4,8, and 11, Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
Other Name: VR-CAP
Active Comparator: R-CHOP

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Rituximab intravenous on Day 1, Cyclophosphamide intravenous on Day 1, Doxorubicin intravenous on Day 1, Vincristine intravenous on Day 1, Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Other Name: R-CHOP

  Eligibility

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

Inclusion Criteria:

  • Male or female patients 18 years or older.
  • Newly Diagnosed non-GCBsubtype of DLBCL (Stage II, III or IV).
  • At least 1 measurable site of disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.
  • Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

  • Prior treatment with VELCADE.
  • Prior extended radiotherapy or chemotherapy for lymphoma
  • More that 150 mg/m2 of prior doxorubicin
  • Major surgery within 3 weeks of study.
  • Peripheral neuropathy or neuralgia of Grade 2 or worse.
  • Active CNS lymphoma
  • Diagnosed or treated for a malignancy other than NHL, with some exceptions
  • Pregnant or

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