drugset / Trial / NCT02583893

Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia

NCT02583893

NaSingle-groupOpen-labelBasic science

Summary

This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine \[MEC\]) in patients with acute myeloid leukemia (AML) that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve patient response. Studying samples of bone marrow from patients treated with sirolimus in the laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and whether changes in biomarker levels can predict how well patients will respond to treatment.

Timeline

Start
2015-10-07
Primary completion
2023-04-17
Completion
2023-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule Oral
Background Cytarabine Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background Mitoxantrone Small molecule Intravenous