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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
Open (Enrolling)
Both
Mantle Cell Lymphoma

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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 HospitalBaltimore, Maryland  21215
Hematology-Oncology Associates of Northern NJMorristown, New Jersey  07962
Cancer Outreach Associates, PCAbingdon, Virginia  24211
Legacy Pharma ResearchBismarck, North Dakota  58501
St. Francis Hosptial and Medical CenterHartford, Connecticut  06105
Center for Cancer Care at Goshen HospitalGoshen, Indiana  46526
Capitol Comp. Cancer CenterJefferson City, Missouri  65109
Nebraska Cancer SpecialistsOmaha, Nebraska  68114
Division of Hematology and Oncology Vanderbilt UniversityNashville, Tennessee  37232