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

Sponsors and Collaborators:	Institute of Cancer Research, United Kingdom Australasian Leukaemia and Lymphoma Group (ALLG)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053092

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	82
Study Start Date:	October 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053092

Locations

Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
United Kingdom, England
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH

Sponsors and Collaborators

Institute of Cancer Research, United Kingdom

Australasian Leukaemia and Lymphoma Group (ALLG)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	CDR0000269136, NCRI-LY05, ALLG-LY05, EU-20230, NCRILG-LY05
Study First Received:	January 27, 2003
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00053092 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Study placed in the following topic categories:

Antimetabolites
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Cyclophosphamide
Fludarabine monophosphate
Immunosuppressive Agents

Lymphatic Diseases
Antineoplastic Agents, Alkylating
Fludarabine
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Alkylating Agents
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Cyclophosphamide
Therapeutic Uses
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Rituximab
Fludarabine monophosphate
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 02, 2009