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 currently recruiting participants.

Verified by Millennium Pharmaceuticals, Inc., January 2010

First Received: July 23, 2008 Last Updated: January 7, 2010 History of Changes

Sponsor:	Millennium Pharmaceuticals, Inc.
Collaborator:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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 Doxorubicin Doxorubicin hydrochloride Rituximab Bortezomib Vincristine sulfate

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:	July 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
VcR-CAP: Experimental 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.
R-CHOP: Active Comparator 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

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

Contacts

Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center

1-866-835-2233

medical@mlnm.com

Show 151 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:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Clinical Research Monitor )
Study ID Numbers:	26866138-LYM-3002
Study First Received:	July 23, 2008
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00722137 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Lymphoma
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Mitosis Modulators
Bortezomib
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases

ClinicalTrials.gov processed this record on February 09, 2010