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| Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Gruppo Italiano Malattie EMatologiche dell'Adulto |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002701 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia
PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: thioguanine Drug: tretinoin Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LEUKEMIA |
Eligibility| Ages Eligible for Study: | 16 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 71 Study Locations| Study Chair: | Petra Muus, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
| Study Chair: | Franco Mandelli, MD | Azienda Policlinico Umberto Primo |
More Information
| Study ID Numbers: | CDR0000064499, EORTC-06952, ITA-GIMEMA-AIEOP-1 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002701 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia adult acute promyelocytic leukemia (M3) |
|
Neoplasm, Residual Antimetabolites Anti-Infective Agents Immunologic Factors Folate 6-Mercaptopurine Cyclophosphamide Leukemia, Myeloid, Acute Etoposide phosphate Vitamin B9 Anti-Bacterial Agents Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute |
Methotrexate Analgesics Etoposide Alkylating Agents Cytarabine Thioguanine Leukemia, Myeloid Folinic Acid Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Folic Acid Idarubicin Busulfan Tretinoin |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Cyclophosphamide 6-Mercaptopurine Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Leukemia Sensory System Agents Therapeutic Uses |
Abortifacient Agents Leukemia, Promyelocytic, Acute Methotrexate Analgesics Dermatologic Agents Alkylating Agents Cytarabine Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Thioguanine Enzyme Inhibitors Leukemia, Myeloid Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antiviral Agents |
