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

Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients (LAM-RAPA)

This study has been completed.

Sponsors and Collaborators:	University Hospital, Toulouse Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:	University Hospital, Toulouse
ClinicalTrials.gov Identifier:	NCT00235560

Purpose

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

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: rapamycin	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cytarabine Cytarabine hydrochloride Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:

response rate [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Enrollment:	50
Study Start Date:	June 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

sirolimus

Detailed Description:

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

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235560

Locations

France
Service d'Hématologie CHU Purpan
Toulouse, France, 31059
Service d'Hématologie, CHU
ANGERS, France, 49100
Service d'Hématologie, Hôpital Jean Minjoz
BESANçON, France, 25000

Sponsors and Collaborators

University Hospital, Toulouse

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

Investigators

Principal Investigator:

RECHER Christian

CHU Toulouse

More Information

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.

Responsible Party:	University Hospital Toulouse ( LLAU Marie-Elise )
Study ID Numbers:	0402008, GOELAMS, PHRC
Study First Received:	September 9, 2005
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00235560
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Toulouse:

AML
Rapamycin
Elderly
Elderly patients not eligible for intensive chemotherapy

Study placed in the following topic categories:

Sirolimus
Leukemia
Clotrimazole
Miconazole
Tioconazole

Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009