NCT06783790

Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

We enrolled 20 patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation of RUNX1::RUNX1T1 or CBFB::MYH11 with C-KIT mutation. The study was divided into induction therapy period and consolidation therapy period, and the study design was as follows: A: Induction therapy period: After patients were screened and enrolled, they began to receive 1-2 cycles of induction therapy, and the specific administration regimen was as follows: Avapritinib 100mg po qd D1-D14, azacitidine 35mg/m2 ih D1-D5, Venetoclax 100mg po qd D1-D14. The 28-day cycle was followed by curative effect evaluation at the end of each cycle. Patients who achieved complete remission entered the consolidation treatment stage. B: Consolidation therapy period: Patients who achieved complete remission after 1-2 cycles of induction therapy continued to receive avapritinib 100mg/d po. monotherapy for consolidation therapy, with a cycle of 28 days and a total of 4 cycles.

Conditions

• AML (Acute Myelogenous Leukemia)

Interventions

Type	Name	Description
DRUG	Avapritinib, azacitidine, Venetoclax	A: Induction therapy period: After patients were screened and enrolled, they began to receive 1-2 cycles of induction therapy, and the specific administration regimen was as follows: Avapritinib 100mg po qd D1-D14, azacitidine 35mg/m2 ih D1-D5, Venetoclax 100mg po qd D1-D14. The 28-day cycle was followed by curative effect evaluation at the end of each cycle. Patients who achieved complete remission entered the consolidation treatment stage. B: Consolidation therapy period: Patients who achieved complete remission after 1-2 cycles of induction therapy continued to receive avapritinib 100mg/d po. monotherapy for consolidation therapy, with a cycle of 28 days and a total of 4 cycles

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: China