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

Toulouse University Hospital

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: rapamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00235560

PHRC

0402008

GOELAMS

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Rapamycine

Experimental group

Treatment:

Drug: rapamycin