Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00641095
- Lead Sponsor
- University College, London
- Brief Summary
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.
- Detailed Description
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.
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.
This trial follows on from the Phase II randomised study of fludarabine/cyclophosphamide combination with or without Rituximab in patients with untreated mantle cell lymphoma. ISRCTN number: NCT00053092
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fludarabine/Cyclophosphamide/Rituximab rituximab Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion Every 28 days Fludarabine/Cyclophosphamide/Rituximab Cyclophosphamide Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion Every 28 days Fludarabine/Cyclophosphamide/Rituximab Fludarabine Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion Every 28 days Fludarabine/Cyclophosphamide Cyclophosphamide Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Every 28 days Fludarabine/Cyclophosphamide Fludarabine Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Every 28 days
- Primary Outcome Measures
Name Time Method Overall survival From date of first administration of treatment until the date of death from any cause, assessed up to a maximum of 60 months Overall survival - Time from date of first administration of treatment until death from any cause
- Secondary Outcome Measures
Name Time Method Progression-free survival From date of first treatment administration until the date of first documented progression or relapse, whichever came first, assessed up to a maximum of 60 months Progression-free survival - Time from date of first administration of treatment to Disease Progression or replapse
Toxicity - Number of patients with >=grade 3 toxicity Within 30 days after last dose of treatment Toxicity - Number of patients who suffer grade 3 or 4 toxicities
Toxicity - Percentage of patients with >=grade 3 toxicity Within 30 days after last dose of treatment Toxicity - Percentage of patients who suffer grade 3 or 4 toxicities
Tumor response duration From date of first documentation of PR or CR until the date of first progression up to a maximum of 60 months Tumor response duration - Time from Complete or Partial Response to disease progression
Trial Locations
- Locations (67)
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
William Harvey Hospital
🇬🇧Ashford, England, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Good Hope Hospital
🇬🇧Birmingham, England, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
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