Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.


Clinical Trial Description

This is a multicenter, single-arm, prospective, and intervention trial. About 30% of core binding factor acute myeloid leukemia (CBF-AML) patients still relapse under current treatment. Some studies have found that KIT mutations, especially the D816V mutation, may predict relapse and decrease overall survival (OS) in CBF-AML. Avapritinib has been approved for the treatment of gastrointestinal stromal tumors with KIT or PDGFRA mutations. Avapritinib was also effective for the treatment of minimal residual disease in acute myeloid leukemia with t (8;21) and KIT mutation failing to immunotherapy after allogeneic hematopoietic stem cell transplantation in a single-center, retrospective report. 11 centers from China carry out the AVACBFKIT regimen including Avapritinib, hypomethylating agents and low dose chemotherapy for the treatment of relapsed or refractory pediatric CBF-AML with KIT mutation. The main focus of this study is to evaluate the efficacy and safety of avapritinib in the regimen. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06316960
Study type Interventional
Source Children's Hospital of Soochow University
Contact Shaoyan Hu, MD, PhD
Phone +86-13771870462
Email hsy139@126.com
Status Recruiting
Phase Phase 2
Start date March 2024
Completion date March 2027

See also
  Status Clinical Trial Phase
Recruiting NCT04984837 - Study of Lacutamab in Peripheral T-cell Lymphoma Phase 2
Recruiting NCT04723914 - Dual Target CAR-T Cells in B-cell Lymphoma Phase 1/Phase 2
Completed NCT04634630 - The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung
Recruiting NCT05320081 - Camrelizumab Combined With CD30 CAR-T in the Treatment of Relapsed/Refractory CD30+ Lymphoma Phase 2
Active, not recruiting NCT04749355 - Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS Phase 2
Recruiting NCT06125483 - TBI/Flu/Bu/Mel Combined With Secondary UCBT in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT N/A
Recruiting NCT05816746 - Decitabine and Anti-PD-1 in R/R DLBCL Phase 2
Not yet recruiting NCT04860674 - A Prospective Study of PD-1 Inhibitor Combined With ICE in the Treatment of Relapsed/Refractory Gray Area Lymphoma Phase 2
Recruiting NCT05274451 - A Study to Investigate LYL797 in Adults With Solid Tumors Phase 1
Recruiting NCT03501758 - Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound
Recruiting NCT04689659 - Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma Phase 2
Recruiting NCT06262386 - Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial N/A