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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


Phase 2
15 Years
60 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Petra Muus, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitair Medisch Centrum St. Radboud - Nijmegen

Authority:

United States: Federal Government

Study ID:

CDR0000066882

NCT ID:

NCT00003758

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute monoblastic leukemia and acute monocytic leukemia (M5)
  • childhood acute monoblastic leukemia and acute monocytic leukemia (M5)
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute eosinophilic leukemia
  • adult acute basophilic leukemia
  • adult acute megakaryoblastic leukemia (M7)
  • childhood acute myeloblastic leukemia without maturation (M1)
  • childhood acute myeloblastic leukemia with maturation (M2)
  • childhood acute myelomonocytic leukemia (M4)
  • childhood acute erythroleukemia (M6)
  • childhood acute eosinophilic leukemia
  • childhood acute basophilic leukemia
  • childhood acute megakaryocytic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • childhood acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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