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Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)

NCT01184898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-31

Study results available
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Summary

The purpose of this study is to evaluate the addition of Sirolimus (rapamycin) to standard chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML). Cancer cells taken from the patients will be studied in the laboratory to see if rapamycin is affecting the mTOR pathway in the cells and if this effect is correlated with how well patients respond to the therapy.

Conditions

Interventions

DRUG

Sirolimus

Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.

DRUG

Mitoxantrone

Mitoxantrone 8mg/m2/day IV

DRUG

Etoposide

100 mg/m2/day IV

DRUG

Cytarabine

1000mg/m2/day IV every 24 hours for 5 days

Sponsors & Collaborators

Principal Investigators

  • Margaret Kasner, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-01-31
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184898 on ClinicalTrials.gov