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

Phase 1

Completed

• Conditions: Leukemia

• Registration Number: NCT00840684
• Lead Sponsor: Institut Paoli-Calmettes

Brief 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-07
• Study First Submitted QC: 2009-02-07
• Study First Posted: 2009-02-10
• Status Verified: 2009-07
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (phase I)
Rate of complete remission (phase II)

Trial Locations

Locations (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France