drugset / Trial / NCT02583893
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
Phase 2
Completed
39 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | Mitoxantrone | Small molecule | — | Intravenous |