Leukemia Clinical Trial
Official title:
A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS
RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, 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 I/II trial is studying the side effects and best dose of laromustine
when given together with daunorubicin and cytarabine in treating patients with acute myeloid
leukemia.
OBJECTIVES:
Primary
- To determine the dose of laromustine that can be combined with daunorubicin
hydrochloride and cytarabine in patients with previously untreated acute myeloid
leukemia with unfavorable cytogenetics. (Phase I)
- To determine the complete remission rate of this regimen as induction therapy. (Phase
II)
Secondary
- To determine the complete response rate.
- To determine the safety profile of this regimen.
- To determine the overall and relapse-free survival.
- To evaluate the prognostic value of the molecular markers FLT3, duplications of MLL,
and Evi-1.
OUTLINE: This is a multicenter, phase I dose-escalation study of laromustine followed by a
phase II study.
- Induction treatment: Patients receive laromustine IV on day 4, daunorubicin
hydrochloride IV on days 1-3, and cytarabine IV continuously on days 1-7. Patients not
attaining complete remission (CR) after first induction receive a second induction
treatment comprising daunorubicin hydrochloride IV on days 1-3 and cytarabine IV twice
daily on days 1-4. Patients in CR after 1 or 2 induction treatments proceed to
consolidation treatment.
- Consolidation treatment: Patients receive mini-consolidation treatment comprising
amsacrine on day 1 and cytarabine IV twice daily on days 1-5 followed by 2 courses of
continuing consolidation treatment comprising mitoxantrone hydrochloride on days 1 and
2 and cytarabine IV over 12 hours on days 1-5.
- Allogeneic or autologous stem cell transplantation: Patients receive busulfan four
times daily for 4 days and melphalan followed by allogeneic or autologous stem cell
transplantation.
After completion of study treatment, patients are followed periodically for 5 years.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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