Selinexor (KPT-330) in Older Patients With Relapsed AML

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

This is a randomized, multicenter, open-label, phase 2 study of the SINE compound, selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Participants age ≥ 60 years with relapsed or refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

Key facts

Study ID

NCT02088541

Run by

Karyopharm Therapeutics Inc

People needed

317

Starts

2014-03-01

Expected to finish

2018-01-08

Last updated by the study team

2023-01-26

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 60 years with relapsed or refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) ≤ 2.
• Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
• Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
• Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included: a hypomethylating agent with at least 2 cycles.
• At least 2 weeks must have elapsed since the last anti-leukemia treatment (with the exception of hydroxyurea) before first dose in this study.

You may not qualify if…

• Treatment with any investigational agent within 3 weeks prior to first dose in this study.
• Presence of central nervous system (CNS) leukemia.
• In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
• Major surgery within 2 weeks of first dose of study drug. Participants must have recovered from the effects of any surgery performed greater than 2 weeks previously.
• Concurrent active malignancy under treatment.
• Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
• Known HIV infection.
• Unable to swallow tablets, or participants with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
• Participants whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.

Where it is running

• Sutter Oncology & Hematology — Sacramento, California, United States
• Stanford Cancer Institute / Stanford University — Stanford, California, United States
• Colorado Blood Cancer Institute/Sarah Cannon Research Institute — Denver, Colorado, United States
• Yale Cancer Center / Yale University — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Winship Cancer Institute / Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• University of Kansas Hospital — Kansas City, Kansas, United States
• Sidney Kimmel Comprehensive Cancer Center / John Hopkins University — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Westchester Medical Center / New York Medical College — Hawthorne, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• New York Presbyterian Hospital / Weill Cornell Medical College — New York, New York, United States
• Duke Cancer Care — Durham, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Milton S. Hershey Medical Center / Penn State — Hershey, Pennsylvania, United States
• Tennessee Oncology/Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center / Vanderbilt University — Nashville, Tennessee, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• Jonsson Comprehensive Cancer Center / University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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