Back to resultsCombination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
fludarabine phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Peter MacCallum Cancer Centre
- Derriford Hospital
Outcomes
Primary Outcome Measures
Response rate
Time to disease progression
Toxicity
Overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00053092
First Posted
January 27, 2003
Last Updated
December 17, 2013
Sponsor
Institute of Cancer Research, United Kingdom
Collaborators
Australasian Leukaemia and Lymphoma Group
1. Study Identification
Unique Protocol Identification Number
NCT00053092
Brief Title
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Cancer Research, United Kingdom
Collaborators
Australasian Leukaemia and Lymphoma Group
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Primary Outcome Measure Information:
Title
Response rate
Title
Time to disease progression
Title
Toxicity
Title
Overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Rule, MD
Organizational Affiliation
Derriford Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Seymour, MD
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Study Chair
Facility Information:
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19197729
Citation
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.
Results Reference
result
Learn more about this trial
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
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