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

December 12, 2016 updated by: City of Hope Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

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

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:

Inclusion criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: cytarabine
Other Names:
  • Cytosar-U
  • Cytosine Arabinoside
  • Depocyt
Drug: idarubicin
Other Names:
  • Idamycin
  • Zavedos
  • 4-demethoxydaunorubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission (CR)
Time Frame: 7 days post completion of induction chemotherapy
The peripheral blood neutrophil count is >= 1.5 x 10^9 / L and platelets more than 100 x 10^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.
7 days post completion of induction chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Marrow at Day 7 Post-Induction Chemotherapy
Time Frame: 7 days post completion of induction chemotherapy
Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)
7 days post completion of induction chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anthony S. Stein, MD, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1994

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (ESTIMATE)

September 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2017

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 93139
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-93139
  • CHNMC-93139-94-03-1
  • CDR0000564537 (REGISTRY: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Clinical Trials on cytarabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe