NCT02573363

Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

Phase I Investigator Sponsored Study to Assess the Tolerability and Efficacy of Selinexor in Combination With High Dose Cytarabine (HiDAC) and Mitoxantrone Chemotherapy for Remission Induction in Acute Myelogenous Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and the best dose of selinexor when give together with standard chemotherapy, high dose cytarabine and mitoxantrone hydrochloride, in treating patients with acute myeloid leukemia. Selinexor may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selinexor together with standard chemotherapy may be a better treatment for patients with acute myeloid leukemia.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine	Given per standard of care
DRUG	Mitoxantrone Hydrochloride	Given per standard of care
DRUG	Selinexor	Given PO

Timeline

• Start date: 2015-10-07
• Primary completion: 2018-01-01
• Completion: 2019-05-03
• First posted: 2015-10-09
• Last updated: 2020-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study