Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00003758|
Recruitment Status : Unknown
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 3, 2004
Last Update Posted : February 9, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cytarabine Drug: idarubicin Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 2|
OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia.
OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Official Title:||Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG|
|Study Start Date :||December 1998|
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): NCT00003758
|Algemeen Ziekenhuis Middelheim|
|Antwerp, Belgium, 2020|
|A.Z. St. Jan|
|Brugge, Belgium, 8000|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Medical School/University of Zagreb|
|Zagreb, Croatia, 41000|
|University Hospital Rebro|
|Zagreb, Croatia, 41000|
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Paris, France, 75743|
|Ospedale San Eugenio|
|Rome, Italy, 00144|
|Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore|
|Rome, Italy, 00168|
|Groot Ziekengasthuis 's-Hertogenbosch|
|'s-Hertogenbosch, Netherlands, 5211 NL|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 ZA|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6252 HB|
|Sint Joseph Ziekenhuis|
|Veldhoven, Netherlands, 5500 MB DB|
|Hospital Escolar San Joao|
|Porto, Portugal, 4200|
|Ibn-i Sina Hospital, Ankara Univeristy|
|Ankara, Turkey, 06100|
|Study Chair:||Petra Muus, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|