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

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ClinicalTrials.gov Identifier: NCT00235560
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : June 20, 2008
Sponsor:
Collaborator:
French Innovative Leukemia Organisation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: rapamycin Phase 2

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008



Intervention Details:
  • Drug: rapamycin
    sirolimus
    Other Name: RAPAMUNE


Primary Outcome Measures :
  1. response rate

Secondary Outcome Measures :
  1. tolerability
  2. bioclinical markers of response


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235560


Locations
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France
Service d'Hématologie, CHU
Angers, France, 49100
Service d'Hématologie, Hôpital Jean Minjoz
BESANçON, France, 25000
Service d'Hématologie CHU Purpan
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
French Innovative Leukemia Organisation
Investigators
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Principal Investigator: RECHER Christian CHU Toulouse

Publications:
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Responsible Party: LLAU Marie-Elise, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00235560     History of Changes
Other Study ID Numbers: 0402008
GOELAMS
PHRC
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008
Keywords provided by University Hospital, Toulouse:
AML
Rapamycin
Elderly
Elderly patients not eligible for intensive chemotherapy
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs