- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003758
Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
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
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.
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2020
- Algemeen Ziekenhuis Middelheim
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Brugge, Belgium, 8000
- A.Z. St. Jan
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Brussels, Belgium, 1000
- Institut Jules Bordet
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Edegem, Belgium, B-2650
- Universitair Ziekenhuis Antwerpen
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Zagreb, Croatia, 41000
- University Hospital Rebro
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Zagreb, Croatia, 41000
- Medical School/University of Zagreb
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Paris, France, 75743
- Hôpital Necker
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Paris, France, 75181
- Hotel Dieu de Paris
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Rome, Italy, 00168
- Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
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Rome, Italy, 00144
- Ospedale San Eugenio
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's-Hertogenbosch, Netherlands, 5211 NL
- Groot Ziekengasthuis 's-Hertogenbosch
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Leiden, Netherlands, 2300 ZA
- Leiden University Medical Center
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Nijmegen, Netherlands, NL-6252 HB
- University Medical Center Nijmegen
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Veldhoven, Netherlands, 5500 MB DB
- Sint Joseph Ziekenhuis
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Porto, Portugal, 4200
- Hospital Escolar San Joao
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Ankara, Turkey, 06100
- Ibn-i Sina Hospital, Ankara Univeristy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Petra Muus, MD, PhD, Universitair Medisch Centrum St. Radboud - Nijmegen
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent adult acute myeloid leukemia
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
- adult acute basophilic leukemia
- adult acute eosinophilic leukemia
- recurrent childhood acute myeloid leukemia
- childhood acute erythroleukemia (M6)
- childhood acute megakaryocytic leukemia (M7)
- childhood acute minimally differentiated myeloid leukemia (M0)
- childhood acute basophilic leukemia
- childhood acute eosinophilic leukemia
- childhood acute myeloblastic leukemia without maturation (M1)
- childhood acute myeloblastic leukemia with maturation (M2)
- childhood acute myelomonocytic leukemia (M4)
- adult acute monoblastic leukemia and acute monocytic leukemia (M5)
- childhood acute monoblastic leukemia and acute monocytic leukemia (M5)
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Idarubicin
Other Study ID Numbers
- CDR0000066882
- EORTC-06956
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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