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Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Alpha Interferon (IFN-A), Low-Dose Cytosine Arabinoside (ARA-C), and Homoharringtonine (HHT)

Phase 2
12 Years
Not Enrolling

Thank you

Trial Information

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Alpha Interferon (IFN-A), Low-Dose Cytosine Arabinoside (ARA-C), and Homoharringtonine (HHT)

OBJECTIVES: I. Determine the effectiveness of low dose cytarabine, homoharringtonine, and
interferon alfa in stimulating a complete cytogenic response in patients with Philadelphia
chromosome positive early chronic phase chronic myelogenous leukemia. II. Evaluate the
duration of the cytogenic response in these patients after this treatment. III. Determine
differential success rates and analyze results by prognostic subsets (e.g., risk group,
splenomegaly, thrombocytosis, age, etc.) in this patient population.

OUTLINE: Patients receive debulking therapy consisting of hydroxyurea until blood count is
at proper level. Patients then receive interferon alfa and cytarabine daily by subcutaneous
injection. Homoharringtonine is administered by continuous infusion on days 1-5. Treatment
continues for 5-7 years in the absence of unacceptable toxicity or disease progression
(accelerated or blastic phase CML). If complete remission is achieved, peripheral blood stem
cells are collected. Patients are followed every 3 months for the first year and every 6
months thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Cytologically confirmed early chronic phase chronic myelogenous
leukemia (CML) Diagnosed within 12 months Philadelphia chromosome positive OR bcr positive
No late chronic phase, accelerated phase, or blastic phase CML

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL Renal:
Creatinine less than 2 mg/dL Cardiovascular: No severe heart disease Other: No psychoses
Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Less than 1 month of prior interferon alfa
Chemotherapy: Less than 1 month of prior cytarabine Prior hydroxyurea allowed Endocrine
therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients with Complete Cytogenic Response

Outcome Time Frame:

Every 3 months

Safety Issue:


Principal Investigator

Hagop M. Kantarjian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

October 2001

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Homoharringtonine
  • HHT
  • cephalotaxus alkaloid
  • cytarabine
  • Interferon Alpha 2-A
  • Roferon-A
  • Ara-C
  • DepotCyt
  • Cytosine Arabinosine Hydrochloride
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009