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	Treatment or Intervention	Phase
acute leukemia childhood cancer hematopoietic/lymphoid cancer Cancer Leukemia cellular diagnosis, childhood acute myeloid leukemia body system/site cancer stage, adult acute myeloid leukemia adult acute myeloid leukemia cellular diagnosis, adult acute myeloid leukemia stage, childhood acute myeloid leukemia childhood acute myeloid leukemia Acute Myeloid Leukemia	Drug: cytarabine  Drug: idarubicin	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  15 Years   -   60 Years

Criteria

PROTOCOL ENTRY 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

--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

--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

Belgium
      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
Croatia
      Medical School/University of Zagreb, Zagreb,  41000,  Croatia
      University Hospital Rebro, Zagreb,  41000,  Croatia
France
      Hopital Necker, Paris,  75743,  France
      Hotel Dieu de Paris, Paris,  75181,  France
Italy
      Ospedale San Eugenio, Rome,  00144,  Italy
      Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome,  00168,  Italy
Netherlands
      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
Portugal
      Hospital Escolar San Joao, Porto,  4200,  Portugal
Turkey
      Ibn-i Sina Hospital, Ankara Univeristy, Ankara,  06100,  Turkey

Study chairs or principal investigators

Petra Muus,  Study Chair,  EORTC Leukemia Cooperative Group   

Study ID Numbers:  CDR0000066882; EORTC-06956
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003758
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08