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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00235560

Acronym

LAM-RAPA

Enrollment

Registered

2005-10-10

Start date

2005-06-30

Completion date

2008-06-30

Last updated

2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

AML, Rapamycin, Elderly, Elderly patients not eligible for intensive chemotherapy

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

Interventions

DRUGrapamycin

sirolimus

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
tolerability	—
bioclinical markers of response	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026