Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Recruitment status was Active, not recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 |
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 |
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| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 3002 | |
| United Kingdom | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Study Chair: | Simon Rule, MD | Derriford Hospital |
| Study Chair: | John Seymour, MD | Peter MacCallum Cancer Centre, Australia |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00053092 History of Changes |
| Other Study ID Numbers: | CDR0000269136, NCRI-LY05, ALLG-LY05, EU-20230, NCRILG-LY05 |
| Study First Received: | January 27, 2003 |
| Last Updated: | May 14, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Fludarabine monophosphate Rituximab Fludarabine Vidarabine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013