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

Conditions

• Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Selinexor oral tablet.
• Hydroxyurea — DRUG
• Ara-C — DRUG
  Ara-C Subcutaneous Injection.

Study Details

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 Dates

Start date

Mar 31, 2014

Status verified

Jan 2023

Primary completion

Jan 8, 2018

Completion

Jan 8, 2018

Study Design

Enrollment

317 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Selinexor approximately 55 mg/m^2 (60 to 120 mg based on BSA)
  Participants under protocol versions (PV) less than (\<) 5.0 (those who had one prior line of acute myeloid leukemia (AML) therapy), receive oral selinexor tablets at a dose of approximately 55 mg/m\^2 (milligrams per square meter) (60 to 120 mg based on body surface area \[BSA\]) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
• Experimental: Selinexor 60 mg (PV <5) (Equivalent to 35 mg/m^2)
  Participants under PV \< 5.0 (those who had one prior line of AML therapy), receive oral selinexor tablets at a fixed dose of 60 mg (equivalent to 35 mg/m\^2), based on BSA, twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
• Experimental: Selinexor 60 mg (PV >=5) (Equivalent to 35 mg/m^2)
  Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), receive oral selinexor tablets at a dose of 60 mg (equivalent to 35 mg/m\^2) twice weekly, on Day 1 and 3 of each week of 4-week cycle (28 days per cycle).
• Active Comparator: Physician's Choice 1 (PV <5)
  Participants under PV \< 5.0 (those who had one prior line of AML therapy) received Best Supportive Care (BSC) which included blood product transfusions, antimicrobials, growth factors as needed, and hydroxyurea.
• Active Comparator: Physician's Choice 2 (PV >=5)
  Participants under PV \>= 5 (PV 5: those who had at least one prior line of AML therapy, PV 5.1: who had at least two prior line of AML therapy), received BSC along with subcutaneous injection of arabinoside cytosine (Ara-C), 20 mg, twice daily, for 10 days, repeated at 28 to 42 day intervals.

Primary Outcome Measure

Overall Survival [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) ]

Locations (26)

Find similar trials in Los Angeles, CA

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