Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06449482
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Acute Myeloid Leukemia, Adult

Eligibility Criteria

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

Interventions

  • Selinexor — DRUG
    three dosage groups were set up, selinexor 60mg QW, 40mg BIW, or 60mg BIW
  • Venetoclax — DRUG
    cycle 1 100mg d1 200mg d2 400mg d3-28 cycle 2-4 400mg d1-d28
  • Azacitidine — DRUG
    75mg/m2 d1-d7 28d/cycle 4 cycles

Study Details

This study is a single arm open exploratory clinical trial to evaluate the efficacy and safety of selinexor combined with venetoclax and azacitidine. This study will be divided into two stages: dose increasing stage and dose expanding stage. In the dose-increasing stage, the study induction therapy was designed using a 3+3 design. The induction therapy and consolidation therapy of the subjects will be administered at RP2D doses. During this study period, there were a total of 4 cycles. The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy. In addition, if the subject does not achieve remission (CR/Cr or PR) after 2 cycles of consolidation treatment (at the end of the 4th course), the study will be terminated by the subject, and the clinical doctor will choose the subsequent treatment for the subject based on clinical experience.

Key Dates

Start date
May 5, 2023
Status verified
Mar 2024
Primary completion
Mar 30, 2025
Completion
Mar 30, 2025

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: selinexor venetoclax Azacitidine
    In the dose-increasing stage, the subject induction therapy was designed using a 3+3 design. selinexor 60mg QW, 40mg BIW, or 60mg BIW, in combination with venetoclax 100mg d1 200mg d2 400mg d3-28, orally once a day, and azacitidine 75mg/m2, d1-7, subcutaneously. The medication regimen was repeated every 28 days. In this case, RP2D is determined based on MTD, safety, and all other data. During this study period, there were a total of 4 courses. The treatment cycle of the subjects will include 2 cycles of induction therapy and up to 2 cycles of consolidation therapy.

Primary Outcome Measure

RP2D of selinexor in this study [ Time Frame: 1 year ]

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