Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
NCT ID: NCT00053092
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2002-10-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rituximab
cyclophosphamide
fludarabine phosphate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Australasian Leukaemia and Lymphoma Group
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Simon Rule, MD
Role: STUDY_CHAIR
Derriford Hospital
John Seymour, MD
Role: STUDY_CHAIR
Peter MacCallum Cancer Centre, Australia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Derriford Hospital
Plymouth, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1080/10428190802688509.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCRI-LY05
Identifier Type: -
Identifier Source: secondary_id
ALLG-LY05
Identifier Type: -
Identifier Source: secondary_id
EU-20230
Identifier Type: -
Identifier Source: secondary_id
NCRILG-LY05
Identifier Type: -
Identifier Source: secondary_id
CDR0000269136
Identifier Type: -
Identifier Source: org_study_id