|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| 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 Procedure: 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: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002701 |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia adult acute promyelocytic leukemia (M3) |
|
Neoplasm, Residual Thioguanine Acute myelogenous leukemia Acute promyelocytic leukemia Leukemia, Myeloid Cyclophosphamide 6-Mercaptopurine Leukemia, Myeloid, Acute Etoposide phosphate Folic Acid Leukemia |
Idarubicin Busulfan Leukemia, Promyelocytic, Acute Tretinoin Methotrexate Mitoxantrone Acute myeloid leukemia, adult Etoposide Acute myelocytic leukemia Cytarabine |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibiotics, Antineoplastic Sensory System Agents Therapeutic Uses Abortifacient Agents Analgesics Alkylating Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents |
