Phase I Study in RAD 001 Patients With Relapse AML

French Innovative Leukemia Organisation31 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML

Interventions

RAD 001DRUG

RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sophie Park

Paris, France

Outcomes

Primary Outcomes

maximal dose tolerated

5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step

Time frame: 40 days

Secondary Outcomes

Biological study

biological study of PI3K/AKT an mTORC1 activation in blast cells

Time frame: Day 1 and day 7

Biological study

concentration mesures of RAD 001 in total blood

Time frame: Day 1 and Day 7

Data from ClinicalTrials.gov

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