National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Phase II Randomized Study of Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Last Modified: 5/13/2009     First Published: 12/21/2002  

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overOtherNCRI-LY05
ALLG-LY05, EU-20230, NCRILG-LY05, NCT00053092

Objectives

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

Entry Criteria

Disease Characteristics:

  • Histologically confirmed previously untreated mantle cell lymphoma requiring therapy
    • Any stage


Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Patient Characteristics:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 3 months

Hematopoietic

  • Not specified

Hepatic

  • 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]

Renal

  • Creatinine no greater than 2.5 times ULN*

 [Note: *Unless related to lymphoma]

Other

  • 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

Expected Enrollment

82

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

Outcomes

Primary Outcome(s)

Response rate
Time to disease progression
Toxicity
Overall survival

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.

Published Results

Eve HE, Linch D, Qian W, et al.: Toxicity of fludarabine and cyclophosphamide with or without rituximab as initial therapy for patients with previously untreated mantle cell lymphoma: results of a randomised phase II study. Leuk Lymphoma 50 (2): 211-5, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

National Cancer Research Institute

Simon Rule, MD, Protocol chair
Ph: 44-1752-517-505

Australasian Leukemia and Lymphoma Group

John Seymour, MD, Protocol chair
Ph: 61-3-9656-1076

Registry Information
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
Trial Start Date 2002-10-01
Registered in ClinicalTrials.gov NCT00053092 1
Date Submitted to PDQ 2002-11-18
Information Last Verified 2007-06-26

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.



Table of Links

1http://clinicaltrials.gov/ct/show/NCT00053092