CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 55 enrolled
Drug / intervention
Sirolimus +2 moredrug
Likely dose
Not stated in 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/NCT01822015
NCT01822015Early Ph 1Completed
CompareCT.gov

A Pilot, Pharmacodynamic Correlate Trial of Sirolimus in Combination With Chemotherapy (Idarubicin, Cytarabine) for the Treatment of Newly Diagnosed Acute Myelogenous Leukemia

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Apr 1, 2013·Updated Apr 29, 2025

In Brief

A Early Phase 1 clinical trial evaluating Sirolimus, Idarubicin, and 1 other intervention for Adult Acute Megakaryoblastic Leukemia (M7) and 13 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sirolimus together with idarubicin and cytarabine may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2013
Enrollment StartMar 15, 2013
Primary CompletionDec 12, 2019
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 13.3 years ago

Interventions

Sirolimusdrug

Given PO

Idarubicindrug

Given IV

Cytarabinedrug

Given IV