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Chemotherapy plus BCG Immunotherapy with or without Allogeneic Tumor Cells for Acute Myeloid Leukemia
Basic Trial Information
Objectives I. Evaluate the effect of the addition of BCG immunotherapy with and without allogeneic leukemic cells to an earlier chemotherapy regimen for acute myeloid leukemia. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with acute myeloid leukemia. Expected Enrollment Protocol closed 12/80. Outline Study randomized for Maintenance only. Induction: 2-Drug Combination Chemotherapy. Daunomycin, DNR, NSC-82151 or Daunomycin-DNA complex, NSC-169533; Cytosine arabinoside, ARA-C, NSC-63878. Maintenance: Arm I: Immunotherapy plus 2-Drug Combination Chemotherapy. BCG-Glaxo, BCG; live allogeneic leukemic cells; DNR (or Daunomycin-DNA complex); ARA-C. Arm active 1974-1978. Arm II: 2-Drug Combination Chemotherapy. DNR (or Daunomycin-DNA complex); ARA-C. Arm active 1974-1978. Arm III: Immunotherapy plus 2-Drug Combination Chemotherapy. BCG; DNR (or Daunomycin-DNA complex); ARA-C. Arm active 1978. Arm IV: Immunotherapy plus Single-agent Chemotherapy and Leucovorin Rescue. BCG; live allogeneic leukemic cells; plus (a) early Intensification with high-dose Methotrexate, MTX, NSC-740 and Citrovorum Factor, CF, NSC-3590 or (b) no early Intensification. Arm active 1978. Trial Lead Organizations Karolinska University Hospital - Huddinge
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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