CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Sirolimus +3 moredrug
Likely dose
Sirolimus 12mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01184898
NCT01184898N/ACompleted
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A Pilot, Pharmacodynamic Correlate, Multi-Institutional Trial of Sirolimus in Combination With Chemotherapy (Mitoxantrone, Etoposide, Cytarabine) for the Treatment of High Risk, Acute Myelogenous Leukemia

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Aug 19, 2010·Updated May 31, 2025

In Brief

A clinical study evaluating Sirolimus, Mitoxantrone, and 2 other interventions for AML. Completed, enrolled 36 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAML
CountriesUnited States
CollaboratorsUniversity of Pennsylvania

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2010
Enrollment StartJul 1, 2010
Primary CompletionJan 1, 2012
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.9 years ago

Interventions

Sirolimusdrug

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

Mitoxantronedrug

Mitoxantrone 8mg/m2/day IV

Etoposidedrug

100 mg/m2/day IV

Cytarabinedrug

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