Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00002701|
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 11, 2003
Last Update Posted : September 20, 2013
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 or disease||Intervention/treatment||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 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|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|
|Study Start Date :||October 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002701
|Study Chair:||Petra Muus, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|
|Study Chair:||Franco Mandelli, MD||Azienda Policlinico Umberto Primo|