Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

Sponsor
Shanghai Tong Ren Hospital
Study ID
NCT05736978
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    75mg/m2 d1-7
  • Venetoclax — DRUG
    d1 100mg, d2 200mg, d3-28 400mg
  • Selinexor — DRUG
    if MRD positive in C1D14, selinexor 60mg D15, D22

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 based on MRD results on day 14 of the first cycle.

Key Dates

Start date
Mar 31, 2023
Status verified
Mar 2023
Primary completion
Mar 1, 2025
Completion
Mar 15, 2027

Study Design

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

Arms

  • Experimental: Treatment regimen based on C1D14 MRD
    Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy will be given azacitidine 75mg/m2, d1-7 and venetoclax 100mg on day 1 and 200mg on day 2, 400mg on day 3-28. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. Patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment 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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