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
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Mantle Cell Lymphoma
Both
Mantle Cell Lymphoma
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
18-25 months
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Millennium Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
26866138-LYM-3002
NCT ID:
NCT00722137
Start Date:
May 2008
Completion Date:
September 2013
Related Keywords:
- Mantle Cell Lymphoma
- Lymphoma
- Lymphoma, Mantle-Cell
Name | Location |
|---|---|
| Sinai Hospital | Baltimore, Maryland 21215 |
| Hematology-Oncology Associates of Northern NJ | Morristown, New Jersey 07962 |
| Cancer Outreach Associates, PC | Abingdon, Virginia 24211 |
| Legacy Pharma Research | Bismarck, North Dakota 58501 |
| St. Francis Hosptial and Medical Center | Hartford, Connecticut 06105 |
| Center for Cancer Care at Goshen Hospital | Goshen, Indiana 46526 |
| Capitol Comp. Cancer Center | Jefferson City, Missouri 65109 |
| Nebraska Cancer Specialists | Omaha, Nebraska 68114 |
| Division of Hematology and Oncology Vanderbilt University | Nashville, Tennessee 37232 |
