Study of Selinexor Combined With Chidamide in Relapsed/Refractory Acute Leukemia (AML) Patients

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05951855
Phase
PHASE2
Status
Unknown

Conditions

  • Acute Myeloid Leukemia (Relapsed/Refractory)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor 60mg/day, weight≥70kg (40mg/day, weight\<70kg) orally on d1,4,8,11,
  • Chidamide — DRUG
    Chidamide 10mg/day, orally on day 1 to 28

Study Details

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor combined with chidamide in the treatment of unfit R/R AML.

Key Dates

Start date
Mar 1, 2023
Status verified
Aug 2022
Primary completion
Sep 1, 2024
Completion
Mar 1, 2025

Study Design

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

Arms

  • Experimental: Selinexor combined with chidamide
    R/R AML who are ineligible for intensive chemotherapy will receive selinexor in combination with chidamide, 28 days per cycle, Selinexor will be used as 40 or 60mg BIW for two weeks, and chidamide will be used as 10mg/d from day 1 to 28. Depending on the level of recovery, patients will either be forced to come off study or have the option to continue the medication, receive maintenance therapy, or pursue an allogeneic stem cell transplant.

Primary Outcome Measure

Number of Participants With ORR [ Time Frame: 28 days after study treatment ]

Central Contacts