Study on Selinexor Combined with Chemotherapy for Treating Acute Myeloid Leukemia in Older Patients

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02835222

Provider View

This clinical trial is exploring how well the drug selinexor works when used with chemotherapy treatments in older patients with acute myeloid leukemia (AML). The study aims to see if this combination can effectively kill more cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This study is testing a new treatment approach for older patients with acute myeloid leukemia (AML). It combines the drug selinexor with standard chemotherapy treatments, including cytarabine and daunorubicin. Selinexor may help stop cancer cells from growing by blocking certain enzymes. The goal is to see if this combination can kill more cancer cells and improve survival rates in patients with AML.

Description

PRIMARY OBJECTIVES:

  • To compare how long patients live when receiving the study treatment versus the standard treatment.

SECONDARY OBJECTIVES:

  • To compare how well patients respond to the study treatment versus the standard treatment, including complete remission rates.
  • To compare how long patients remain free of disease after treatment.
  • To assess the rate of stem cell transplants in patients.
  • To compare the side effects of the study treatment versus the standard treatment.

OUTLINE:

INDUCTION THERAPY: Patients receive cytarabine through an IV on days 1-7, daunorubicin through an IV on days 1-3, and selinexor by mouth twice a week starting on day 1. This treatment lasts for 14 days unless the disease progresses or side effects are too severe.

RE-INDUCTION THERAPY: If the disease does not respond, patients receive cytarabine through an IV on days 1-5, daunorubicin through an IV on days 1-2, and selinexor by mouth twice a week. This treatment also lasts for 14 days unless the disease progresses or side effects are too severe.

CONSOLIDATION THERAPY: Patients in remission receive cytarabine through an IV every 12 hours on days 1-3, and selinexor by mouth twice a week starting on day 1. This treatment repeats every 42 days for up to 3 courses unless the disease progresses or side effects are too severe.

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

Eligibility Criteria

Inclusion Criteria

  • Must have a new diagnosis of acute myeloid leukemia (AML) that has not been treated, except for certain allowed treatments.
  • Cannot have a specific type of AML known as core binding factor AML.
  • Cannot have secondary AML from previous cancer treatments, except for certain cases.
  • Must not have certain genetic abnormalities in the cancer cells.
  • Patients 60 years or younger must not have a specific FLT3 mutation.
  • Must be 18 years or older.
  • Must be in good health to undergo induction therapy.
  • Must have certain blood and organ function levels within specified limits.
  • Women of childbearing potential must use two forms of birth control and have a negative pregnancy test.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have received other treatments for AML, except for certain allowed treatments.
  • Cannot have another active cancer requiring treatment, except for certain skin cancers.
  • Cannot have had a stem cell-supported chemotherapy regimen in the past 6 months.
  • Cannot have known central nervous system involvement.
  • Cannot have a history of severe allergic reactions to similar drugs.
  • Cannot have uncontrolled illnesses or psychiatric conditions that would interfere with the study.
  • Cannot have known HIV or hepatitis infections.
  • Pregnant or breastfeeding women cannot participate.
  • Cannot have conditions that interfere with swallowing or absorbing the study drug.
  • Cannot have had prior exposure to a similar drug.

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