Tests avapritinib after stem cell transplant in acute myeloid leukemia with KIT mutations
Tests avapritinib as maintenance therapy in adults with acute myeloid leukemia and KIT mutations.
Plain-language title generated from the registry record
Registry title: Avapritinib Maintenance for AML With KIT Mutations
Key facts
- Where
- Shanghai, 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 people with acute myeloid leukemia (AML) and a KIT mutation who had a first stem cell transplant from a donor and are in remission. They would take avapritinib to help keep the leukemia from coming back.
- Age
- From 14 to 70 years.
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia (including secondary AML) in complete remission (CR), with no leukemia cells found on a sensitive test (negative MFC-MRD) before starting treatment. Expected survival of at least 3 months. ECOG PS 0-2.
- Earlier treatment
- A first allogeneic stem cell transplant (allo-HSCT) for AML. Cannot have had a TKI inhibitor that proved ineffective. Cannot be taking other targeted AML therapies.
- Biomarker or test result
- A KIT mutation found at diagnosis (any location in the KIT gene). A FLT3-ITD mutation at enrollment means the person cannot join.
Main reasons for not taking part
- A FLT3-ITD mutation at enrollment
- Graft-versus-host disease needing systemic immunosuppressive treatment before maintenance therapy
- Another cancer that needs treatment
- Active, uncontrolled infection
- HIV-positive, or active hepatitis B or C needing antiviral treatment
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 70 years old?
Source: NCT06765915, who can take part
Where in China
- Ruijin Hospital of Shanghai Jiaotong UniversityShanghai, ChinaContact: Xiaoxia HU, DoctorNo longer taking part
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
- Ruijin Hospital
- Trial code
- NCT06765915
- Record updated
- 9 January 2025
- Original description
A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.Read full original descriptionShow less
Avapritinib Maintenance Following Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia With KIT Mutations
A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.
Inclusion: Age≥ 14 years old; First allo-HSCT for AML (including secondary AML) ; KIT mutation at diagnosis (no restriction on locus for kit mutation; CR and negative MFC-MRD prior to initiation of maintenance therapy; Absolute neutrophil count ≥ 1.0 x 109 /L, platelets ≥ 75 x 109 /L, hemoglobin ≥ 80 g/L before maintenance; Normal functioning of major organs and laboratory findings in accordance with the following criteria:AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g/L (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\^9/L (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\^9/L (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%; ECOG PS 0-2 points; Expected survival ≥ 3 months; Patient consent.
Exclusion: concurrently receiving other targeted therapies for AML; Prior treatment with a TKI inhibitor that proved ineffective; with concurrent FLT3-ITD mutations at enrollment; Acute/chronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy; Accompanied by other malignant tumors requiring treatment; Have important organ-based diseases: e.g., myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal failure; Active, uncontrolled infection; HIV-positive, active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy; The investigator believes that there are other conditions that make the patient unsuitable for participation in this study; Other interventional clinical studies have been enrolled; Men and women of childbearing potential are unwilling to use contraception during and for 12 months after treatment.