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 has been completed.
Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01040871
First received: December 29, 2009
Last updated: February 1, 2013
Last verified: February 2013
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Purpose
This is a randomized, open-label, active-control, parallel-group, multicenter, multinational 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 | 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: | Interventional |
| Study Design: | Allocation: Randomized 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:
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:
- Complete response (CR) rate [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 164 |
| Study Start Date: | January 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned 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 breast feeding
- Active systemic infection
- Documented of suspected human immunodeficiency virus (HIV)/AIDS
- Uncontrolled or severe cardiovascular disease
- Known allergies,hypersensitivity or intolerance to study drugs
- Serious medical condition that could interfere with study
- Concurrent treatment with another investigational agent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040871
Locations
| Belgium | |
| Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie | |
| Gent, Belgium | |
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01040871 History of Changes |
| Other Study ID Numbers: | 26866138-LYM-2034 |
| Study First Received: | December 29, 2009 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse 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 |
ClinicalTrials.gov processed this record on May 22, 2013