NCT06658925

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

The Safety and Efficacy of Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Adult Ph + Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. ).

Conditions

• Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)
• HSCT
• Tyrosine Kinase Inhibitor

Interventions

Type	Name	Description
DRUG	Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.	Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2024-10-26
• Last updated: 2024-10-26