Fludarabine and Cyclophosphamide With or Without Rituximab in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Recruitment status was Recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating mantle cell lymphoma.
PURPOSE: This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate Genetic: fluorescence in situ hybridization Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma |
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Tumor response [ Designated as safety issue: No ]
| Estimated Enrollment: | 550 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the overall survival in patients with untreated mantle cell lymphoma treated with fludarabine phosphate and cyclophosphamide with vs without rituximab.
Secondary
- To determine the progression-free survival in patients treated with this regimen.
- To determine the toxicity of this regimen in these patients.
- To determine the tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine phosphate IV or orally once daily and oral cyclophosphamide once daily on days 1-3. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive rituximab IV on day 1 and fludarabine phosphate IV or orally once daily and oral cyclophosphamide once daily on days 1-3. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow and blood sample collection periodically for molecular studies. Samples are analyzed for morphology; sIgM, sIgD, CD19, CD20, CD5, CD10, CD23, bcl-1, bcl-6 via immunophenotyping and immunohistochemistry; and t(11,14) translocation via interphase fluorescence in situ hybridization (FISH) mutational analysis.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma (MCL), meeting the following criteria:
- Diagnosis confirmed by examination of representative material (lymph nodes or bone marrow) together with a typical immunophenotype CD5+, CD23-, sIgM, cyclin D1 nuclear positivity is desirable but not essential
- Central review of histology will be performed on diagnostic material
- Molecular or cytogenetic confirmation of diagnosis is not required
- Previously untreated disease at any stage requiring therapy in the opinion of the treating physician
PATIENT CHARACTERISTICS:
Life expectancy ≥ 3 months
- Life expectancy not severely limited by other illness
- Creatinine clearance ≥ 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during study therapy
- No known serological positivity for HBV, HCV, or HIV
- No concurrent uncontrolled serious medical conditions
- No severe impairment of renal or liver function (alkaline phosphatase, bilirubin or creatinine > 2.5 times upper limit of normal) not related to lymphoma
- No known hypersensitivity to murine proteins
- No prior malignancy in the past 5 years, except for nonmelanoma skin tumor or curatively resected carcinoma in situ of the uterine cervix
- No history of a psychological illness or condition that, in the opinion of the investigator, may adversely affect compliance with study medication
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy
Contacts and Locations
Show 67 Study Locations| Principal Investigator: | Simon Rule, MD | Derriford Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00641095 History of Changes |
| Other Study ID Numbers: | CDR0000589227, CRUK-UCL-MCLIII, EUDRACT-2006-001965-41, MREC-02/6/31, EU-20824 |
| Study First Received: | March 20, 2008 |
| Last Updated: | October 6, 2009 |
| Health Authority: | Unspecified |
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