Rapamycin in Combination With Low-dose Aracytin in Elderl... | NCT00235560

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

NCT00235560

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Feb 29, 2024Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Acute Myeloid Leukemia

Interventions

rapamycin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Oct 6, 2005

First Posted Date

Oct 10, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2024

Last Update Posted Date

Feb 29, 2024Actual

Name	Class
French Innovative Leukemia Organisation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Label	Type	Description	Intervention Names
Rapamycine	Experimental		Drug: rapamycin

Name	Type	Description	Arm Group Labels	Other Names
rapamycin	Drug	sirolimus	Rapamycine	RAPAMUNE

Measure	Description	Time Frame
response rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
RECHER Christian	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Hématologie, CHU		Angers		49100	France
Service d'Hématologie, Hôpital Jean Minjoz

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15550488	Background	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.

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

ID	Type	Description	Link
GOELAMS
PHRC