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.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00722137
First received: July 23, 2008
Last updated: December 10, 2013
Last verified: December 2013
  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
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: VELCADE
Drug: Prednisone
Drug: Vincristine
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:


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: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VcR-CAP
Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
Drug: Rituximab
Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Drug: Cyclophosphamide
Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Drug: Doxorubicin
Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Drug: VELCADE
VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles
Drug: Prednisone
Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Active Comparator: R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Drug: Rituximab
Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
Drug: Cyclophosphamide
Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles
Drug: Doxorubicin
Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles
Drug: Prednisone
Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles
Drug: Vincristine
Vincristine intravenous on Day 1of 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bortezomib
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on October 23, 2014