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

This study has been completed.
Sponsor:
Collaborator:
Australasian Leukaemia and Lymphoma Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053092
First received: January 27, 2003
Last updated: December 17, 2013
Last verified: June 2007

January 27, 2003
December 17, 2013
October 2002
Not Provided
  • Response rate [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00053092 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: rituximab
  • Drug: cyclophosphamide
  • Drug: fludarabine phosphate
Not Provided
Eve HE, Linch D, Qian W, Ross M, Seymour JF, Smith P, Stevens L, Rule SA. 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. 2009 Feb;50(2):211-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
February 2009
Not Provided

DISEASE CHARACTERISTICS:

  • Histologically confirmed previously untreated mantle cell lymphoma requiring therapy

    • Any stage

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   Australia
 
NCT00053092
CDR0000269136, NCRI-LY05, ALLG-LY05, EU-20230, NCRILG-LY05
Not Provided
Not Provided
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
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP