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Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00002800
First received: November 1, 1999
Last updated: July 1, 2013
Last verified: July 2013

November 1, 1999
July 1, 2013
July 1996
March 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002800 on ClinicalTrials.gov Archive Site
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Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL

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 high-dose cytarabine plus idarubicin in treating patients with newly diagnosed acute or chronic myelogenous leukemia or myelodysplastic syndrome.

OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy with high-dose cytarabine plus a single high dose of idarubicin in patients with previously untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or immunophenotypic markers in AML patients for use in the study of residual disease.

OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day. Patients eligible for the second consolidation course may have peripheral blood stem cells collected following this regimen. Patients with an HLA-compatible donor then proceed to allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21) or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks, then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients are followed for survival.

PROJECTED ACCRUAL: 60 patients will be entered over 3 years.

Interventional
Phase 2
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Neutropenia
  • Biological: filgrastim
  • Biological: lintuzumab
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: idarubicin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2003
March 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: One of the following hematologic malignancies that is ineligible for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous leukemia Accelerated or blastic phase (greater than 10% blasts in marrow) chronic myelogenous leukemia Poor-risk myelodysplastic syndrome, defined as: Refractory anemia with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy RAEB in transformation Chronic myelomonocytic leukemia No acute promyelocytic leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure Other: No concurrent active malignancy No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior therapy except biologic agent alone or hydroxyurea

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002800
96-044, CDR0000064897, NCI-V96-0941
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Peter Maslak, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP