Avapritinib with azacitidine and venetoclax for relapsed acute myeloid leukemia after transplant
Tests avapritinib, azacitidine and venetoclax in adults whose acute myeloid leukemia returned after transplant.
Plain-language title generated from the registry record
Registry title: Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML) has come back after a donor stem cell transplant. The leukemia must carry a C-KIT mutation and the CBFB::MYH11 or RUNX1::RUNX1T1 gene change.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- AML that came back after an allogeneic (donor) stem cell transplant. This can be leukemia cells in the blood, leukemia outside the bone marrow, or a molecular or cytogenetic relapse. ECOG performance score of 0-2.
- Earlier treatment
- People who had midostaurin, or a C-KIT inhibitor aimed at the mutation whose disease then got worse during that treatment, cannot join.
- Biomarker or test result
- C-KIT D816 or C-KIT N822 mutation in the bone marrow, and either the CBFB::MYH11 gene or the RUNX1::RUNX1T1 fusion gene.
Main reasons for not taking part
- Known allergy to KIT inhibitor type drugs
- FLT3-ITD mutation in relapsed or refractory disease (except at a low gene ratio)
- HIV infection, or active HBV or HCV infection
- Active GVHD that is not under control
- Leukemia in the central nervous system
Read by machine on 12 November 2026.
Where in China
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaContact: Erlie JiangTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06783790
- Record updated
- 20 January 2025
- Original description
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.Read full original descriptionShow less
An Exploratory Clinical Study of the Safety and Efficacy of Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
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.
Inclusion: Subjects met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood >5% (except for other causes such as bone marrow recovery period) or extramedullary leukemia cell infiltration or molecular or cytogenetic recurrence; Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations; Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected; Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points; Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen saturation >91%; ④ Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes < 2 times the upper limit of normal (for the same age); Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.
Exclusion: Patients who have received previous treatment with Midostaurin; Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment; Known allergy to KIT inhibitor drug analogues; FLT3-ITD mutation in patients with recurrent/refractory disease (except low gene ratio); HIV infected persons, HBV, HCV active infected persons; Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases; With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards, aGVHD classification refer to the improved Glucksberg standard); Central nervous system leukemia.