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Keep this study
Lead
Alliance for Clinical Trials in Oncology
With
National Cancer Institute (NCI)
OBJECTIVES: I. Compare the overall survival of interferon alfa refractory chronic myelogenous leukemia patients treated with homoharringtonine to those treated with hydroxyurea. II. Compare the time to progression of these patients treated with these two drugs. III. Estimate the complete and major cytogenetic response and describe the serial cytogenetics of these patients treated with these two drugs.
OUTLINE: This is a randomized study. Patients are randomized to receive one of two treatments. Arm I: Induction: Patients receive homoharringtonine IV continuously over 24 hours daily for 14 days. Induction continues every 28 days for a maximum of 6 courses or until hematopoietic recovery. Maintenance: Patients receive homoharringtonine IV continuously over 24 hours daily for 5 days. Treatment repeats every 28 days. Arm II: Induction: Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts are achieved. Maintenance: Patients receive oral hydroxyurea daily every 28 days to maintain acceptable blood counts. Treatment in both arms continues for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for a maximum of 10 years.
PROJECTED ACCRUAL: A total of 480 patients (240 per arm) will be accrued for this study within 4 years.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Documentation of Disease:
* BCR/ABL protein detectable by immunoblotting
* BCR/ABL rearrangement detectable by Southern blot analysis
* Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL
* BCR/ABL translocation present by fluorescence in situ hybridization (FISH).
2. Prior Treatment:
2.1 No previous therapy with homoharringtonine (HHT)
You may not be if
2.3 Patients must have failed an adequate trial (5M units/m2/day) of alpha-Interferon (IFN) or IFN/ara-C to be eligible, as defined below (any ONE of the following):
* Failure to achieve a complete hematologic response after 6 months of IFN therapy.
* Failure to achieve any cytogenetic response (i.e., still 100% Ph+) after 12 months of IFN therapy.
* Intolerable adverse effects of IFN therapy after at least one month of IFN treatment. Significant documented toxicity of ≥ grade 3 (using NCI Common Toxicity Criteria guidelines) due to IFN is required.
* Loss of a prior hematologic remission or cytogenetic response to IFN.
* A two-fold increase in WBC count when compared to WBC count when IFN therapy was initiated.
3. Age ≥ 16 years
5. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Clareo Health | Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa
