A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Sponsor
Shanghai Tong Ren Hospital
Study ID
NCT05736965
Phase
PHASE2
Status
Recruiting
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Conditions

  • AML, Adult

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    Selinexor 60mg, PO d3,10,17
  • Azacitidine — DRUG
    Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
  • Venetoclax — DRUG
    Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14

Study Details

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.

Key Dates

Start date
Feb 20, 2023
Status verified
Mar 2023
Primary completion
Mar 30, 2025
Completion
Apr 30, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SAV arm
    Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects.

Primary Outcome Measure

Percentage of Participants With Composite Complete Remission [ Time Frame: From the study start up to death (up to approximately 2 years; ) ]

Central Contacts

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