Phase I Study in RAD 001 Patients With Relapse AML

NCT ID: NCT01074086

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

AML

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

RAD 001 in relapsed AML

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RAD 001

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

Group Type EXPERIMENTAL

RAD 001

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RAD 001

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

everolimus

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sophie PARK, MD MS

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Didier BOUSCArY, MD MS

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sophie Park

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.

Reference Type DERIVED
PMID: 23321953 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RAD 001

Identifier Type: -

Identifier Source: org_study_id