NCT06765915Not yet recruitingPhase 2
Avapritinib Maintenance for AML With KIT Mutations
Avapritinib Maintenance Following Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia With KIT Mutations
Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 5 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06765915
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 47
- From 1 Feb 2025 to the primary completion date, 1 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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
- 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;
Who the study is looking for
- 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
Age in the registry: 14 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital of Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.