Actively Recruiting
Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-01-20
20
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.
CONDITIONS
Official Title
Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrence of leukemia after allogeneic transplantation confirmed by >5% leukemia cells in peripheral blood or bone marrow, extramedullary infiltration, or molecular/cytogenetic relapse
- Presence of C-KIT D816 or N822 mutations detected by bone marrow molecular biology
- Detection of CBFB::MYH11 or RUNX1::RUNX1T1 fusion genes
- Eastern Cancer Collaboration Group (ECOG) physical status score between 0 and 2
- Liver, kidney, and cardiopulmonary functions within specified limits: creatinine 1.5 times upper normal limit, left ventricular ejection fraction 50%, blood oxygen saturation above 91%, total bilirubin 2 times ULN, ALT and AST 2.5 times ULN, myocardial enzymes less than twice the upper limit for age
- Willingness to participate and ability to complete all trial procedures with signed informed consent
You will not qualify if you...
- Known allergy to KIT inhibitor drug analogues
- Previous treatment with Midostaurin
- Prior treatment with mutation-specific C-KIT inhibitors with disease progression during treatment
- FLT3-ITD mutation in recurrent/refractory disease except for low gene ratio
- Active infection with HIV, HBV, or HCV
- Uncontrolled cardiovascular, cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infections, or other significant diseases
- Uncontrolled active graft-versus-host disease (GVHD) according to NIH and Glucksberg standards
- Central nervous system leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
E
Erlie Jiang
CONTACT
Y
Yigeng Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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