Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma (MCLPIII)
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|ClinicalTrials.gov Identifier: NCT00641095|
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: Cyclophosphamide Drug: Fludarabine||Phase 2 Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma|
|Actual Study Start Date :||December 7, 2006|
|Actual Primary Completion Date :||November 23, 2011|
|Actual Study Completion Date :||May 22, 2015|
Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3 Rituximab 375mgs/m2 day 1 iv infusion
Every 28 days
concentrate for solution for infusion
Film coated tablet
Active Comparator: Fludarabine/Cyclophosphamide
Fludarabine 40mgs/m2 oral days 1-3 Cyclophosphamide 250mgs/m2 oral days 1-3
Every 28 days
Film coated tablet
- Overall survival [ Time Frame: 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
- Progression-free survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within 30 days after last dose of treatment ]Toxicity - Percentage of patients who suffer grade 3 or 4 toxicities
- Tumor response duration [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641095
Show 67 Study Locations
|Principal Investigator:||Simon Rule, MD||Derriford Hospital|