A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
NCT05736965 · 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.
Conditions
- AML, Adult
Interventions
- DRUG
-
Selinexor 60mg, PO d3,10,17
- DRUG
-
Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
- DRUG
-
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
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
- 2023-02-20
- Primary Completion
- 2025-03-30
- Completion
- 2027-04-30
Countries
- China
Study Locations
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