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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
rapamycin
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, Rapamycin, Elderly, Elderly patients not eligible for intensive chemotherapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Hématologie, CHU
  • Service d'Hématologie, Hôpital Jean Minjoz
  • Service d'Hématologie CHU Purpan

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

tolerability
bioclinical markers of response

Full Information

First Posted
September 9, 2005
Last Updated
June 19, 2008
Sponsor
University Hospital, Toulouse
Collaborators
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT00235560
Brief Title
Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients
Acronym
LAM-RAPA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Toulouse
Collaborators
French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, Rapamycin, Elderly, Elderly patients not eligible for intensive chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rapamycin
Other Intervention Name(s)
RAPAMUNE
Intervention Description
sirolimus
Primary Outcome Measure Information:
Title
response rate
Secondary Outcome Measure Information:
Title
tolerability
Title
bioclinical markers of response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RECHER Christian
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hématologie, CHU
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Service d'Hématologie, Hôpital Jean Minjoz
City
BESANçON
ZIP/Postal Code
25000
Country
France
Facility Name
Service d'Hématologie CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15550488
Citation
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. doi: 10.1182/blood-2004-06-2494. Epub 2004 Nov 18.
Results Reference
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Rapamycin in Combination With Low-Dose Aracytin in Elderly Acute Myeloid Leukemia Patients

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