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

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other NCRI-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

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

Outcomes

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.

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
Date Submitted to PDQ		2002-11-18
Information Last Verified		2007-06-26

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