Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
NCT ID: NCT00003758
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
1998-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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cytarabine
idarubicin
allogeneic bone marrow transplantation
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
15 Years
60 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Principal Investigators
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Petra Muus, MD, PhD
Role: STUDY_CHAIR
Universitair Medisch Centrum St. Radboud - Nijmegen
Locations
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Algemeen Ziekenhuis Middelheim
Antwerp, , Belgium
A.Z. St. Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Medical School/University of Zagreb
Zagreb, , Croatia
University Hospital Rebro
Zagreb, , Croatia
Hotel Dieu de Paris
Paris, , France
Hopital Necker
Paris, , France
Ospedale San Eugenio
Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , Italy
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Sint Joseph Ziekenhuis
Veldhoven, , Netherlands
Hospital Escolar San Joao
Porto, , Portugal
Ibn-i Sina Hospital, Ankara Univeristy
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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EORTC-06956
Identifier Type: -
Identifier Source: secondary_id
CDR0000066882
Identifier Type: -
Identifier Source: org_study_id
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