Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results
NCT05736978 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2023-03-15
Summary
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.
Conditions
- AML
- MRD
Interventions
- DRUG
-
75mg/m2 d1-7
- DRUG
-
d1 100mg, d2 200mg, d3-28 400mg
- DRUG
-
if MRD positive in C1D14, selinexor 60mg D15, D22
Sponsors & Collaborators
-
Shanghai Tong Ren Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2025-03-01
- Completion
- 2027-03-15
Countries
- China
Study Locations
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