Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00235560
First received: September 9, 2005
Last updated: June 19, 2008
Last verified: June 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

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:
    Drug: rapamycin
    sirolimus
    Other Name: RAPAMUNE
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
Angers, France, 49100
Service d'Hématologie, Hôpital Jean Minjoz
BESANçON, France, 25000
Service d'Hématologie CHU Purpan
Toulouse, France, 31059
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:

Responsible Party: LLAU Marie-Elise, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00235560     History of Changes
Other Study ID Numbers: 0402008, GOELAMS, PHRC
Study First Received: September 9, 2005
Last Updated: June 19, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
AML
Rapamycin
Elderly
Elderly patients not eligible for intensive chemotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013