NCT00235560

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

September 9, 2005

Last Update Submit

February 27, 2024

Conditions

Acute Myeloid Leukemia

Keywords

AMLRapamycinElderlyElderly patients not eligible for intensive chemotherapy

Outcome Measures

Primary Outcomes (1)

  • response rate

Secondary Outcomes (2)

  • tolerability

  • bioclinical markers of response

Study Arms (1)

Rapamycine

EXPERIMENTAL
Drug: rapamycin

Interventions

rapamycinDRUG

sirolimus

Also known as: RAPAMUNE
Rapamycine

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service d'Hématologie, CHU

Angers, 49100, France

Location

Service d'Hématologie, Hôpital Jean Minjoz

Besançon, 25000, France

Location

Service d'Hématologie CHU Purpan

Toulouse, 31059, France

Location

Related Publications (1)

  • 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.

    PMID: 15550488BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • RECHER Christian

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

October 10, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

FR(3)