Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.

First Received on July 23, 2008. Last Updated on January 13, 2012 History of Changes

Sponsor:	Millennium Pharmaceuticals, Inc.
Collaborator:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00722137

Purpose

This is a randomized, open-label, multicentre, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in patients who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

Condition	Intervention	Phase
Mantle Cell Lymphoma	Drug: Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation 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:

Progression free survival [ Time Frame: 18-25 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: 18-25 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	486
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VcR-CAP Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone	Drug: Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, 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 per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles. Other Name: VcR-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 by mouth 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.
Diagnosis of mantle cell lymphoma (Stage II, III or IV).
At least 1 measurable site of disease.
No prior therapies for mantle cell lymphoma.
Not eligible for bone marrow transplantation.

Exclusion Criteria:

Prior treatment with VELCADE.
Prior anti-neoplastic (including unconjugated therapeutic antibodies), experimental or radiation therapy, radioimmunoconjugates or toxin immunoconjugates for the treatment of mantle cell lymphoma.
Major surgery.
Active systemic infection requiring treatment and patients with known diagnosis of HIV or active Hepatitis B.
Peripheral neuropathy or neuropathic pain of Grade 2 or worse.
Diagnosed or treated for a malignancy other than mantle cell lymphoma (MCL) within 1 year of randomization, or who were previously diagnosed with a malignancy other than MCL and have any radiographic or biochemical marker evidence of malignancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722137

Show 150 Study Locations

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Medical Monitor

Millennium Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00722137 History of Changes
Other Study ID Numbers:	26866138-LYM-3002
Study First Received:	July 23, 2008
Last Updated:	January 13, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Mantle-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
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 24, 2012