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Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma Clinical research trials and Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma  Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
For Condition: stage 4 mantle cell lymphoma,contiguous stage 2 mantle cell lymphoma,noncontiguous stage 2 mantle cell lymphoma,stage 3 mantle cell lymphoma,stage 1 mantle cell lymphoma
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) , Australian Lymphoma Leukemia Group
Synopsis: 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: Randomizedphase 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SimonRule, Study Chair, Derriford Hospital
Peter MacCallum Cancer Centre *Recruiting*
East Melbourne, Victoria, 3002
Australia
Recruiting John Seymour 61-3-9656-1700
Derriford Hospital *Recruiting*
Plymouth, England, PL6 8DH
United Kingdom
Recruiting Simon Rule 44-1752-517-505
Additional Information:
Study ID Numbers: CDR0000269136; EU-20230,ALLG-LY05,NCRI-LY05,NCRILG-LY05
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053092
Other Noncontiguous Stage 2 Mantle Cell Lymphoma Studies:
1. Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
2. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
3. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
4. Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
5. Rituximab and Cladribine in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Related Studies:
Other noncontiguous stage 2 mantle cell lymphoma Clinical Trials
Other England Clinical Trials
Other Plymouth Clinical Trials
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
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