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NCT Number: NCT00235560

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

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service d'Hématologie, CHU, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapamycin

Drug

sirolimus

Other names: RAPAMUNE

Primary outcomes

  1. response rate

Secondary outcomes

  1. tolerability

  2. bioclinical markers of response

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • French Innovative Leukemia Organisation

Registry information

Official study 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)

Acronym: LAM-RAPA

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 10, 2005
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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