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A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older

Phase 2
56 Years
Not Enrolling

Thank you

Trial Information

A Phase II Study Of Induction With Daunorubicin, Cytarabine, And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older


- Determine the safety and efficacy of cyclosporine, daunorubicin, and cytarabine in
older patients with previously untreated acute myeloid leukemia.

- Determine the frequency and severity of toxic effects of this regimen in these

- Determine, preliminarily, the frequency and prognostic significance of functional and
phenotypic P-glycoprotein expression and cytogenetics in patients treated with this

- Determine, preliminarily, the pharmacokinetic characteristics of this regimen in these

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive cyclosporine IV and daunorubicin IV continuously on
days 1-3 and cytarabine IV continuously on days 1-7. Patients who achieve complete
response (CR) after chemotherapy receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV
or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover.
Patients who maintain CR after 2 courses of induction therapy proceed to consolidation

- Consolidation therapy: Patients receive treatment as in induction therapy with
cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5. Patients
achieving CR receive an additional course of chemotherapy beginning at least 14 days
after completion of the first course of cytarabine.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 25-64 patients will be accrued for this study within 13

Inclusion Criteria


- Morphologically confirmed acute myeloid leukemia (AML)

- Differential diagnosis of AML based on FAB classification system

- M0-M7 (No M3)

- No blastic transformation of chronic myelogenous leukemia

- Must be currently registered on protocols SWOG-9007 and SWOG-S9910



- 56 and over

Performance status

- Zubrod 0-3 (for patients 56 to 60 years of age) OR

- Zubrod 0-2 (for patients 61 to 70 years of age) OR

- Zubrod 0-1 (for patients 71 years of age and over)

Life expectancy

- Not specified


- Not specified


- Bilirubin no greater than 2 times upper limit of normal (ULN) unless elevated
unconjugated hyperbilirubinemia is secondary to Gilbert's syndrome or hemolysis and
not to liver dysfunction

- AST and/or ALT no greater than 4 times ULN


- Creatinine no greater than 1.5 times ULN AND/OR

- Creatinine clearance greater than 40 mL/min


- Left ventricular function normal

- Ejection fraction at least 50% by MUGA or echocardiogram

- No unstable cardiac arrhythmias

- No unstable angina


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer that is currently in complete remission


Biologic therapy

- No concurrent pegfilgrastim


- At least 30 days since prior low-dose cytarabine (less than 100 mg/m^2/day) for
myelodysplastic syndromes and recovered

- Prior hydroxyurea to control high cell counts allowed

- No prior systemic chemotherapy for acute leukemia

- Concurrent single-dose intrathecal chemotherapy allowed

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR)

Outcome Time Frame:

After induction therapy is completed

Safety Issue:


Principal Investigator

Thomas R. Chauncey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Veterans Affairs


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

January 2010

Related Keywords:

  • Leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult pure erythroid leukemia (M6b)
  • adult erythroleukemia (M6a)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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