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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT02835222
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Untreated Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    Given IV
  • Daunorubicin Hydrochloride — DRUG
    Given IV
  • Selinexor — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Feb 2, 2018
Status verified
Mar 2026
Primary completion
Feb 26, 2027
Completion
Feb 26, 2027

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 2 (Selinexor) cytarabine, daunorubicin and selinexor
    INDUCTION: Cytarabine IV on days 1-7, daunorubicin hydrochloride IV on days 1-3, and selinexor PO twice weekly from day 1. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: 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: In remission receive cytarabine IV every 12 hours for a total 6 doses 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.
  • Active Comparator: Standard of Care - Cytarabine and daunorubicin
    INDUCTION: Cytarabine IV on days 1-7, daunorubicin hydrochloride IV on days 1-3. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Disease has not responded receive cytarabine IV on days 1-5, daunorubicin hydrochloride IV on days 1-2. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: In remission receive cytarabine IV every 12 hours for a total 6 doses days 1-3. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall survival [ Time Frame: Up to 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Center of Wake Forest UniversityWinston-SalemNorth Carolina27157-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Winston-Salem, NC

By research site
Comprehensive Cancer Center of Wake Forest University· Winston-Salem, NCVirginia Commonwealth University Massey Cancer Center· Richmond, VA

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