VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid Leukemia

Phase 2

• Conditions: Leukemia

• Registration Number: NCT00354276
• Lead Sponsor: Vion Pharmaceuticals

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as VNP40101M 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 VNP40101M followed by cytarabine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

Primary

* Determine the complete response rate in older patients with poor-risk, de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy.

Secondary

* Determine the probability of overall survival, leukemia-free survival, and progression-free survival of patients treated with this regimen.

* Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

* Induction therapy: Patients receive VNP40101M IV over 60 minutes on day 1 (course 1). Patients without evidence of disease progression who have responding but residual disease receive a second course of VNP40101M once between days 35-60. Patients achieving complete response or partial response after induction therapy proceed to consolidation therapy.

* Consolidation therapy: Beginning between days 45-90, patients receive cytarabine IV continuously over 5 days (course 1). Patients may receive a second course of cytarabine at the discretion of the investigator.

After completion of study treatment, patients are followed periodically for up to 36 months.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-20
• Primary Completion: 2008-12
• Status Verified: 2009-05
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete response rate

Secondary Outcome Measures

Name	Time	Method
Leukemia-free survival

Trial Locations

Locations (3)

Hopital Haut Leveque; 🇫🇷 Pessac, France

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States

University Hospital of Wales; 🇬🇧 Cardiff, Wales, United Kingdom