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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053092
• Other study ID #: CDR0000269136
• Secondary ID: NCRI-LY05ALLG-LY
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2003
• Last updated: December 17, 2013
• Start date: October 2002
• Est. completion date: February 2009

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Biological:
• rituximab

Drug:
• cyclophosphamide

• fludarabine phosphate

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
United Kingdom	Derriford Hospital	Plymouth	England

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Australasian Leukaemia and Lymphoma Group

Countries where clinical trial is conducted

Australia,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Time to disease progression			No
Primary	Toxicity			Yes
Primary	Overall survival			No