drugset / Trial / NCT06658925

Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL

NCT06658925

Phase 2 Not yet recruiting 50 enrolled Institute of Hematology & Blood Diseases Hospital, China
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. The number of patients is expected to be 50 cases. The enrolled patients plan to receive Olverembatinib as a post-transplant treatment regimen, including maintenance therapy to prevent recurrence and preemptive treatment. Hematopoietic reconstitution ( neutrophil \> 0.5 × 10 \^ 9 / L, platelet \> 50 × 10 \^ 9 / L ) was evaluated after enrollment. From 2 months to 3 months after transplantation, Olverembatinib 40 mg QOD was added for maintenance treatment until 2 years after transplantation. During maintenance treatment, Olverembatinib dose ( dose range 20 mg QOD to 40 mg QOD ) can be adjusted according to blood picture, biochemical index or other oral drugs ( triazole drugs, etc. ).

Timeline

Start
2024-11-01
Primary completion
2027-08-31
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Olverembatinib Small molecule 20 mg
Subject Olverembatinib Small molecule 40 mg