Phase I Study in RAD 001 Patients With Relapse AML

Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01074086

Enrollment

Registered

2010-02-24

Start date

2008-02-29

Completion date

2012-12-31

Last updated

2012-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

Keywords

RAD 001 in relapsed AML

Brief summary

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

Detailed 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.

Interventions

DRUGRAD 001

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

Study design

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
maximal dose tolerated	40 days	5 steps of RAD 001 doses from 10mg to 50 mg : 3 patienst for each step

Secondary

Measure	Time frame	Description
Biological study	Day 1 and day 7	biological study of PI3K/AKT an mTORC1 activation in blast cells

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026