Selinexor With Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients

Untreated Adult Acute Myeloid Leukemia Clinical Trial

Official title: An Investigator-Sponsored Randomized Phase II Study of Selinexor in Combination With Induction/Consolidation Therapy in Acute Myeloid Leukemia Patients

Status Recruiting

Clinical Trial Summary

This pilot phase II trial studies how well selinexor works when given together with induction, consolidation, and maintenance therapy in treating older patients with acute myeloid leukemia. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin 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. Selinexor with induction, consolidation, and maintenance therapy may kill more cancer cells in older patients with acute myeloid leukemia.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To compare the overall survival of patients receiving the proposed study regimen versus standard of care (defined as time from randomization to death from any cause).

SECONDARY OBJECTIVES:

I. To compare the response rate (Complete remission (CR), complete remission with incomplete count recovery (CRi) as per Dhoner et. al.) of patients receiving the proposed study regimen versus standard of care (SOC).

II To compare disease free survival in patients receiving the proposed study regimen vs standard of care (defined as time from randomization to relapse or death from any cause).

III. To assess the rate of allogeneic stem cell transplantation

IV. To compare the toxicity of the proposed study regimen vs standard of care.

OUTLINE:

INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7, daunorubicin hydrochloride IV on days 1-3, and selinexor orally (PO) twice weekly from day 1. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.

RE-INDUCTION THERAPY: Patients whose disease has not responded receive cytarabine IV on days 1-5, daunorubicin hydrochloride IV on days 1-2, and selinexor PO twice weekly. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION THERAPY: Patients in remission receive cytarabine IV every 12 hours on days 1-3, and selinexor PO twice weekly from day 1. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 14 days and then every 3 months for up to 1 year. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Untreated Adult Acute Myeloid Leukemia

• NCT number: NCT02835222
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-713-5878
• Email: dfunes@wakehealth.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2, 2018
• Completion date: June 2025