Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: cytarabine (Drug); idarubicin (Drug); allogeneic bone marrow transplantation (Procedure); autologous bone marrow transplantation (Procedure); peripheral blood stem cell transplantation (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Petra Muus, MD, PhD, Study Chair, Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen
Summary
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.
Clinical Details
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 design: Treatment
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
A.Z. St. Jan, Brugge 8000, Belgium
Algemeen Ziekenhuis Middelheim, Antwerp 2020, Belgium
Institut Jules Bordet, Brussels 1000, Belgium
Universitair Ziekenhuis Antwerpen, Edegem B-2650, Belgium
Medical School/University of Zagreb, Zagreb 41000, Croatia
University Hospital Rebro, Zagreb 41000, Croatia
Hopital Necker, Paris 75743, France
Hotel Dieu de Paris, Paris 75181, France
Ospedale San Eugenio, Rome 00144, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome 00168, Italy
Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch 5211 NL, Netherlands
Leiden University Medical Center, Leiden 2300 ZA, Netherlands
Sint Joseph Ziekenhuis, Veldhoven 5500 MB DB, Netherlands
University Medical Center Nijmegen, Nijmegen NL-6252 HB, Netherlands
Hospital Escolar San Joao, Porto 4200, Portugal
Ibn-i Sina Hospital, Ankara Univeristy, Ankara 06100, Turkey
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 1998
Last updated: May 23, 2008
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