Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

June 19, 2008

Start Date ^†

June 2005

Current Primary Outcome Measures ^†

response rate [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00235560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

tolerability [ Designated as safety issue: Yes ]
bioclinical markers of response [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

tolerability
bioclinical markers of response

Descriptive Information

Brief Title ^†

Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients

Official Title ^†

Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)

Brief Summary

These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.

Detailed Description

Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Acute Myeloid Leukemia

Intervention ^†

Drug: rapamycin

Study Arms / Comparison Groups

Publications *

Recher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. Epub 2004 Nov 18.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Age > 60 y.
Informed consent
de novo or secondary LAM(CML excluded) not elligible for intensive chemotherapy.
Previously untreated

Exclusion Criteria:

Renal impairment (serum creatinin >2N)
Hepatic impairment (TGO ou TGP > 5N), une cholestase (Phosphatases Alcalines or gamma-GT > 5N),bilirubin > 3N
- Blast crisis CML
- Acute Promyelocytic Leukemia

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00235560

Responsible Party

LLAU Marie-Elise, University Hospital Toulouse

Secondary IDs ^††

GOELAMS, PHRC

Study Sponsor ^†

University Hospital, Toulouse

Collaborators ^††

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Investigators ^†

Principal Investigator:

RECHER Christian

CHU Toulouse

Information Provided By

University Hospital, Toulouse

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.