NCT01035502

A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

A Phase II Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Clavis Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first course of a remission-induction treatment with cytarabine (ara-C). In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

Detailed description

Elacytarabine (CP-4055) is a pro-drug of ara-C currently used in the treatment of patients with acute myeloid leukaemia. Patients with nucleoside transporter deficiency (hENT1) seem to have less benefit from cytarabine compared to those with a high expression of the transporter. Preclinical studies indicate that elacytarabine is independent of this transporter. Therefore, patients with low expression of hENT1 and treated with elacytarabine are anticipated to have a better outcome compared to patients treated with ara-C. The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied. Patients will be treated with elacytarabine plus idarubicin independent of their hENT1 status. Determination of the patients' hENT1 expression level will be done retrospectively. This study will also explore the safety profile of elacytarabine in combination with idarubicin.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Elacytarabine plus idarubicin	Elacytarabine 1000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle. Idarubicin will be administered IV at a fixed dose of 12 mg/ m2/d IV on d 1-3 q3w. It is intended that patients receive remission-induction treatment either as two combination courses, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d or one combination course, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d followed by one course elacytarabine 2000 mg/m2/d single therapy.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2009-12-18
• Last updated: 2013-09-27

Locations

8 sites across 4 countries: United States, France, Germany, Norway