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COMPLETEDPHASE2

Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)

NCT00528398•City of Hope Medical Center

View on ClinicalTrials.gov

Summary

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES: * Determine the complete remission rate (CR). * Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy. * Further evaluate the toxicity of this regimen. OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Eligibility

Age

16 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Newly diagnosed acute myeloid leukemia (AML)
•* Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
•* FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
•Previously untreated with radiotherapy or chemotherapy
•* Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
•Patients with prior myelodysplastic syndrome are eligible
•Extramedullary leukemia allowed
•AML with lymphoid markers allowed
•See Disease Characteristics
+2 more criteria

Exclusion Criteria

•Blastic transformation of chronic myelogenous leukemia
•Biphenotypic leukemia
•FAB M3 disease (acute promyelocytic leukemia)
•PATIENT CHARACTERISTICS:
•Life expectancy ≥ 6 weeks
•Total bilirubin \< 1.5 g/dL
•AST and ALT \< 5 times upper limit of normal (ULN)
•Creatinine \< 1.5 mg/dL OR creatinine clearance \> 70 mL/min
•Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
•HIV antibody-negative
+2 more criteria

Locations (2)

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Key Dates

Start Date

September 1, 1994

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

February 6, 2017

Enrollment

111

ACTUAL participants

Conditions

Leukemia

Interventions

cytarabine

DRUG

idarubicin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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