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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT00235560
Collaborator
French Innovative Leukemia Organisation (Other)
50
3
36
16.7
0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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)
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Outcome Measures

Primary Outcome Measures

  1. response rate []

Secondary Outcome Measures

  1. tolerability []

  2. bioclinical markers of response []

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Service d'Hématologie, CHU Angers France 49100
2 Service d'Hématologie, Hôpital Jean Minjoz BESANçON France 25000
3 Service d'Hématologie CHU Purpan Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse
  • French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: RECHER Christian, CHU Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00235560
Other Study ID Numbers:
  • 0402008
  • GOELAMS
  • PHRC
First Posted:
Oct 10, 2005
Last Update Posted:
Jun 20, 2008
Last Verified:
Jun 1, 2008

Study Results

No Results Posted as of Jun 20, 2008