Actively Recruiting
Exploratory Study of Avapritinib With Azacitidine and Venetoclax for Relapsed AML After Allogeneic Stem Cell Transplantation
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-01-20
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of avapritinib combined with azacitidine and venetoclax in treating patients with recurrent acute myeloid leukemia (AML) who have specific genetic mutations (C-KIT mutation with RUNX1::RUNX1T1 or CBFB::MYH11) after undergoing allogeneic hematopoietic stem cell transplantation. This is a single-center, prospective, single-arm exploratory clinical study focused on this patient group. The treatment is divided into two periods: induction and consolidation. During induction, patients receive 1-2 cycles of avapritinib (100 mg daily for 14 days), azacitidine (35 mg/m2 intravenously for 5 days), and venetoclax (100 mg daily for 14 days) in a 28-day cycle, followed by evaluation of treatment response. Patients who achieve complete remission proceed to consolidation therapy, which involves avapritinib monotherapy (100 mg daily) for four 28-day cycles. Participants will undergo evaluations after each induction cycle to assess treatment response, including measuring overall response rate at 2 months. Further assessments after consolidation therapy and safety monitoring for up to 2 years are included. The study involves clinical exams, laboratory tests, and monitoring of organ function to understand the treatment effects and safety over time. Total participation duration covers induction, consolidation, and safety follow-up periods.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Recurrent acute myeloid leukemia after allogeneic stem cell transplantation with leukemia or bone marrow cells >5% in peripheral blood or extramedullary leukemia or molecular/cytogenetic recurrence
- Presence of C-KIT D816 or N822 mutations detected by bone marrow molecular biology
- Detection of CBFB::MYH11 or RUNX1::RUNX1T1 fusion gene
- Physical status score 0-2 on the Eastern Cancer Collaboration Group (ECOG) scale
- Liver, kidney, and heart-lung functions within specified limits before enrollment
- Willingness to participate and sign informed consent, able to complete all trial procedures
You will not qualify if you...
- Known allergy to KIT inhibitor drug analogues
- Prior treatment with Midostaurin
- Previous use of mutation-specific C-KIT inhibitors with disease progression during treatment
- Presence of FLT3-ITD mutation in recurrent/refractory disease (except low gene ratio)
- Active infection with HIV, HBV, or HCV
- Uncontrolled cardiovascular, cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infections, or other diseases
- Uncontrolled active graft-versus-host disease (GVHD)
- Central nervous system leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each cycle lasts 28 days
Participants receive 1 to 2 cycles of induction therapy with Avapritinib, azacitidine, and Venetoclax to treat relapsed acute myeloid leukemia after stem cell transplantation.
1 visit at the end of each 28-day cycle for response evaluation
Duration - 4 cycles of 28 days each
Participants who achieve complete remission after induction therapy continue with 4 cycles of consolidation therapy using Avapritinib monotherapy.
Visits scheduled for each consolidation cycle
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
E
Erlie Jiang
Y
Yigeng Cao
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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