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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma  Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
For Condition: stage 3 adult diffuse large cell lymphoma,stage 1 adult diffuse large cell lymphoma,contiguous stage 2 adult diffuse large cell lymphoma,noncontiguous stage 2 adult diffuse large cell lymphoma,stage 4 adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
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 whether combination chemotherapy is more effective with or without rituximab in treating patients who have non-Hodgkin's lymphoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of four different combination chemotherapy regimens with or without rituximab in treating patients who have non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Compare the time to treatment failure in patients with CD20-positive diffuse large B-cell non-Hodgkin's lymphoma treated with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like chemotherapy with vs without rituximab. - Compare the tumor control, progression rate, and complete remission rate in patients treated with these regimens. - Compare the disease-free and overall survival rate of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, bulky disease (no vs yes), International Prognostic Index score (0 vs 1), and chemotherapy (CHOP vs CHOEP vs PMitCEBO vs MACOP-B). Patients are randomized to 1 of 2 treatment arms. - Patients receive 1 of the following chemotherapy regimens according to participating country: - CHOP: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisone or prednisolone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. - CHOEP-21: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. - PMitCEBO: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; vincristine IV and bleomycin IV on day 8; and oral prednisolone daily during weeks 1-4 and every other day during week 5. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. - MACOP-B: Patients receive cyclophosphamide IV and doxorubicin IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV and vincristine IV on days 8, 36, and 64; bleomycin IV and vincristine IV on days 22, 50, and 78; and oral or intramuscular prednisone on days 1-84. Treatment continues in the absence of disease progression or unacceptable toxicity. - Patients receive arm I regimens (according to participating country) and rituximab as follows: - CHOP and rituximab: Patients receive CHOP as in arm I and rituximab IV on day 1. - CHOEP-21 and rituximab: Patients receive CHOEP-21 as in arm I and rituximab IV on day 1. - PMitCEBO and rituximab: Patients receive PMitCEBO as in arm I and rituximab IV on day 1 during courses 1 and 4; on day 8 during courses 2 and 5; and on day 1 at 1 and 4 weeks after completion of the last course of PMitCEBO chemotherapy. - MACOP-B and rituximab: Patients receive MACOP-B as in arm I and rituximab IV on days 1, 22, 43, 64, 85, and 106. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within approximately 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma according to REAL classification - Diagnosed within the past 6 weeks - CD20+ disease - Ann Arbor stage II, III, or IV disease or stage I bulky disease - International Prognostic Index (IPI) score of 0 or 1 - Score 0 defined by all of the following: - Stage I or II disease - ECOG performance status of 0 or 1 - Lactic dehydrogenase (LDH) no greater than upper limit of normal (ULN) - Score 1 defined by 1 of the following: - Stage I or II disease; ECOG performance status of 0 or 1; and LDH greater than ULN - Stage I or II disease; ECOG performance status 2 or 3; and LDH no greater than ULN - Stage III or IV disease; ECOG performance status 0 or 1; and LDH no greater than ULN - Previously untreated disease - Mediastinal B-cell lymphoma allowed - No secondary lymphoma after prior chemotherapy or radiotherapy for other malignancies - No transformed lymphoma - No primary CNS lymphoma - No primary gastrointestinal (MALT) lymphoma - No post-transplant lymphoproliferative disorder PATIENT CHARACTERISTICS: Age - 18 to 60 Performance status - See Disease Characteristics - ECOG 0-3 Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2.0 mg/dL* - Transaminases no greater than 3 times normal* - No active chronic hepatitis B or C infection NOTE: *Unless related to lymphoma Renal - Creatinine no greater than 2 times normal* NOTE: *Unless related to lymphoma Cardiovascular - No myocardial infarction within the past 6 months - No uncompensated heart failure - No dilatative cardiomyopathy - No coronary heart disease with ST segment depression on ECG - No severe uncompensated hypertension Pulmonary - No chronic lung disease with hypoxemia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No known allergic reactions against foreign proteins - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No concurrent disease that would preclude study treatment - No active infections requiring systemic antibiotics or antiviral medications - No severe uncompensated diabetes mellitus - No clinical signs of cerebral dysfunction - No severe psychiatric disease PRIOR CONCURRENT THERAPY: Biologic therapy - No prior murine antibodies Chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - No concurrent response-adapted (slow response or unconfirmed complete response) radiotherapy Surgery - Not specified Other - No prior lymphoma-specific treatment - More than 12 weeks since prior participation in another clinical trial - No prior participation in this study - No other concurrent study medication
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KevinImrie, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Royal Victoria Hospital, Barrie *Recruiting*
Barrie, Ontario, L4M 6M2
Canada
Recruiting Bryn Pressnail 705-728-9802
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Kang Howson-Jan 519-685-5194
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Andrew Belch 780-432-8757
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Pierre Desjardins 450-466-5065
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Douglas Stewart 403-944-1707
Newfoundland Cancer Treatment and Research Foundation *Recruiting*
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Recruiting Kirsty Tompkins 709-777-8062
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Margot Burnell 506-648-6884
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
Trillium Health Centre *Recruiting*
Mississauga, Ontario, L5B 1B8
Canada
Recruiting John Gapski 905-848-7160
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting John Matthews 613-533-6329
Hopital du Saint-Sacrement, Quebec *Recruiting*
Quebec City, Quebec, G1S 4L8
Canada
Recruiting Guy Cantin 418-649-5727
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 8L6
Canada
Recruiting Isabelle Bence-Bruckler 613-737-8152
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting Imran Ahmad 306-655-2603
Grand River Regional Cancer Centre *Recruiting*
Kitchner, Ontario, N2G 1G3
Canada
Recruiting Robert Stevens 519-749-4370
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 2Y9
Canada
Recruiting Darrell White 902-473-7922
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Kevin Imrie 416-480-4757
Northeastern Ontario Regional Cancer Centre - Sudbury *Recruiting*
Sudbury, Ontario, P3E 5J1
Canada
Recruiting Jordan Herst 705-522-6237, Ext. 2320
Centre Hospitalier de l'Universite de Montreal *Recruiting*
Montreal, Quebec, H2L 4MI
Canada
Recruiting Danielle Charpentier 514-890-8200
Additional Information:
Study ID Numbers: CDR0000309053; CAN-NCIC-LY9,MINT-M39045,ROCHE-CAN-NCIC-LY9
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064116
Other Stage 3 Adult Diffuse Large Cell Lymphoma Studies:
1. Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
2. Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
3. Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma
4. Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Older Patients With Previously Untreated Non-Hodgkin's Lymphoma
5. Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma
Related Studies:
Other stage 3 adult diffuse large cell lymphoma Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
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