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
- response rate []
Secondary Outcome Measures
- tolerability []
- 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
Keywords provided by ,
,
Additional relevant MeSH terms: