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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00126191 |
The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.
Condition | Intervention | Phase |
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Burkitt Lymphoma Non-Hodgkins Lymphoma Atypical Burkitt Lymphoma |
Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Methotrexate Drug: Leucovorin Drug: Ifosfamide Drug: Etoposide Drug: Cytarabine Drug: Mesna |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Low Risk: Experimental
Regimen A
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Drug: Rituximab
Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1
Drug: Cyclophosphamide
Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
Drug: Doxorubicin
Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
Drug: Vincristine
Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
Drug: Methotrexate
Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle
Drug: Leucovorin
Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
Drug: Cytarabine
Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle
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High Risk: Experimental
Regimen A followed by Regimen B
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Drug: Rituximab
Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1
Drug: Cyclophosphamide
Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
Drug: Doxorubicin
Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
Drug: Vincristine
Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
Drug: Methotrexate
Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle
Drug: Leucovorin
Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
Drug: Ifosfamide
High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle
Drug: Etoposide
High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle
Drug: Cytarabine
Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle
Drug: Mesna
High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory data (within 2 weeks of study registration):
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Ann S. La Casce, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Ann LaCasce, MD ) |
Study ID Numbers: | 04-336 |
Study First Received: | August 2, 2005 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00126191 |
Health Authority: | United States: Institutional Review Board |
Burkitt Lymphoma atypical Burkitt lymphoma Non-Hodgkin's Lymphoma rituximab |
Lymphoma, small cleaved-cell, diffuse Leucovorin Cyclophosphamide Etoposide phosphate Lymphoma, B-Cell Burkitt's lymphoma Methotrexate Epstein-Barr Virus Infections Lymphoma Etoposide Cytarabine Immunoproliferative Disorders Rituximab Vincristine |
Doxorubicin Herpesviridae Infections Folic Acid Virus Diseases Lymphatic Diseases Ifosfamide Burkitt Lymphoma B-cell lymphomas DNA Virus Infections Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Mesna Isophosphamide mustard |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Tumor Virus Infections Reproductive Control Agents Antibiotics, Antineoplastic Neoplasms, Experimental Therapeutic Uses Vitamins Abortifacient Agents Micronutrients |
Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Immune System Diseases Growth Substances Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Antiviral Agents Pharmacologic Actions |