Phase I Study in RAD 001 Patients With Relapse AML

French Innovative Leukemia Organisation

Status and phase: Completed; Phase 1

Conditions: AML

Treatments: Drug: RAD 001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01074086

RAD 001

Details and patient eligibility

About

A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse

Full description

The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients from 18 to 65 years old
• AML in relapse more than 1 year after CR
• inform consent signed

Exclusion criteria

• age more than 65
• cardiac insufficiency
• renal insufficiency
• hepatic disease
• other type of AML
• blastic MCL
• HIV positive serology
• other malignancy
• pulmonary infection

Trial design

31 participants in 1 patient group

RAD 001

Experimental group

Description:

RAD 001 in day 1 and day 7 from 10 mg to 50 mg

Treatment:

Drug: RAD 001