Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053092
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : December 18, 2013
Australasian Leukaemia and Lymphoma Group
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without rituximab in treating mantle cell lymphoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine and cyclophosphamide combined with rituximab to that of fludarabine and cyclophosphamide alone in treating patients who have mantle cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate Phase 2

Detailed Description:


  • Compare the response rates in patients with previously untreated mantle cell lymphoma treated with fludarabine and cyclophosphamide with or without rituximab.
  • Compare the time to disease progression in patients treated with these regimens.
  • Compare the toxicity of these regimens, in terms of adverse event profile, in these patients.
  • Compare the overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms:

  • Arm I: Patients receive fludarabine IV* and cyclophosphamide IV* on days 1-3.
  • Arm II: Patients receive rituximab IV on day 1 and fludarabine IV* and cyclophosphamide IV* on days 2-4.

NOTE: *In both arms, fludarabine and cyclophosphamide may be administered orally instead of IV.

Treatment repeats every 28 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 56-82 patients (28-41 per treatment arm) will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
Study Start Date : October 2002
Actual Study Completion Date : February 2009

Primary Outcome Measures :
  1. Response rate
  2. Time to disease progression
  3. Toxicity
  4. Overall survival

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed previously untreated mantle cell lymphoma requiring therapy

    • Any stage



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 3 months


  • Not specified


  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)^*
  • Alkaline phosphatase no greater than 2.5 times ULN^*
  • Hepatitis B and hepatitis C negative NOTE: *Unless related to lymphoma


  • Creatinine no greater than 2.5 times ULN^* NOTE: *Unless related to lymphoma


  • No other malignancy within the past 5 years except non-melanoma skin cancer or curatively resected carcinoma in situ of the cervix
  • No prior psychological illness or condition that would preclude study compliance
  • No known hypersensitivity to murine proteins
  • No concurrent uncontrolled medical conditions
  • No other illness that would severely limit life expectancy
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053092

Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Australasian Leukaemia and Lymphoma Group
Study Chair: Simon Rule, MD Derriford Hospital
Study Chair: John Seymour, MD Peter MacCallum Cancer Centre, Australia

Publications of Results: Identifier: NCT00053092     History of Changes
Other Study ID Numbers: CDR0000269136
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic