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

NCT ID: NCT00528398

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-09-30
• Study Completion Date: 2015-12-31

Brief 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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (idarubicin, cytarabine)

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.

Group Type: EXPERIMENTAL

cytarabine

Intervention Type: DRUG

idarubicin

Intervention Type: DRUG

Interventions

cytarabine

Intervention Type: DRUG

idarubicin

Intervention Type: DRUG

Other Intervention Names

Cytosine Arabinoside; Cytosar-U; Depocyt; 4-demethoxydaunorubicin; Idamycin; Zavedos

Eligibility Criteria

Inclusion Criteria

• 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
• Prior hydroxyurea or corticosteroids allowed
• At least 48 hours since prior and no concurrent itraconazole or fluconazole

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

PRIOR CONCURRENT THERAPY:

• More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony S. Stein, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Countries

United States

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-93139

Identifier Type: -

Identifier Source: secondary_id

CHNMC-93139-94-03-1

Identifier Type: -

Identifier Source: secondary_id

CDR0000564537

Identifier Type: REGISTRY

Identifier Source: secondary_id

93139

Identifier Type: -

Identifier Source: org_study_id