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

Tracking Information

First Received Date ^ICMJE

January 27, 2003

Last Updated Date

May 14, 2009

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Response rate
Time to disease progression
Toxicity
Overall survival

Change History

Complete list of historical versions of study NCT00053092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

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.

Detailed 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Biological: rituximab
Drug: cyclophosphamide
Drug: fludarabine phosphate

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00053092

Responsible Party

Study ID Numbers ^ICMJE

CDR0000269136, NCRI-LY05, ALLG-LY05, EU-20230, NCRILG-LY05

Study Sponsor ^ICMJE

Institute of Cancer Research, United Kingdom

Collaborators ^ICMJE

Australasian Leukaemia and Lymphoma Group (ALLG)

Investigators ^ICMJE

Study Chair:	Simon Rule, MD	Derriford Hospital
Study Chair:	John Seymour, MD	Peter MacCallum Cancer Centre, Australia

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2007

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