Avapritinib in Relapsed Refractory or MRD-positive CBF-AML With KIT Mutations
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
AML with t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as CBF-AML. KIT mutations are common in CBF-AML, which have a worse prognosis.This study is aimed to evaluate the efficacy of Avapritinib, an highly specific inhibitor of the KIT gene, in CBF-AML with KIT mutations.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:
• Patients with acute myeloid leukemia accompanied by t(8; 21)/RUNX1-RUNX1T1, or inv(16)/t(16; 16)/CBFβ-MYH11;
• Accompanied by KIT mutation
• Disease recurrence after the first remission, or the mol-MRD remains positive after the morphologic remission of AML.
• No active infection.
• Liver function: TBIL≤ 2×ULN,ALT/AST≤ 3×ULN, CCr ≥ 50ml/min，NYHA grading ≤2; SaO2 \>92%.
• ECOG \<2;
⁃ (11) Predicted survival \> 12 weeks.
Locations
Other Locations
China
First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Suning Chen
chensuning@sina.com
+8613814881746
Backup
Haiping Dai
daihaiping@126.com
13914086271
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Treatment Group
The treatment group will receive avapritinib orally. The dosage is 100mg to 300mg qd, allowed to combine with other chemotheray drugs.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University