NCT00840684

Laromustine, Daunorubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

A PHASE I-II MULTICENTER STUDY OF THE CLORETAZINE-DAUNORUBICIN-ARACYTINE COMBINATION FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH UNFAVORABLE CYTOGENETICS

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	amsacrine
DRUG	busulfan
DRUG	cytarabine
DRUG	daunorubicin hydrochloride
DRUG	laromustine
DRUG	melphalan
DRUG	mitoxantrone hydrochloride
PROCEDURE	allogeneic hematopoietic stem cell transplantation
PROCEDURE	autologous hematopoietic stem cell transplantation

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-05-01
• First posted: 2009-02-10
• Last updated: 2011-05-13

Locations

1 site across 1 country: France