Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: rapamycin

• Registration Number: NCT00235560
• Lead Sponsor: University Hospital, Toulouse

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

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Informed consent
• de novo or secondary LAM (CML excluded) not elligible for intensive chemotherapy.
• Previously untreated

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rapamycine	rapamycin	-

Primary Outcome Measures

Name	Time	Method
response rate

Secondary Outcome Measures

Name	Time	Method
tolerability
bioclinical markers of response

Trial Locations

Locations (3)

Service d'Hématologie, Hôpital Jean Minjoz; 🇫🇷 BESANçON, France

Service d'Hématologie, CHU; 🇫🇷 Angers, France

Service d'Hématologie CHU Purpan; 🇫🇷 Toulouse, France