NCT05466175

A Study of Olverembatinib in the Treatment of Ph+ ALL

A Multicenter, Prospective Clinical Study of Olverembatinib Combined With Chemotherapy in the Treatment of de Novo Adult Philadelphia Chromosome-positive Acute Lymphoid Leukemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Chen Suning · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of a novel third-generation TKI Olverembatinib. The main purpose of the study is to evaluate the efficacy and safety of Olverembatinib in Ph+ ALL patients.

Detailed description

Eligible participants will receive an 28-day induction regimen of Olverembatinib (40mg, QOD) combined with VP-chemotherapy, followed by 4 cycles of Hyper-CVAD A/B treatment (each lasting 28 days). If complete molecular response (CMR) is achieved at the 3rd month, participants will receive another three cycles of Hyper-CVAD A/B treatment. Maintenance therapy would be given for at least 1 year with monthly courses of vincristine, prednisone and Olverembatinib. If participants fail to achieve CMR at the 3rd month, or patients with an available matched donor had the option to proceed to allogeneic stem cell transplantation (allo-HSCT) at the discretion of the treating physician. Olverembatinib would be administered at the time of hematopoietic reconstruction for at least 1 year. Intrathecal injection would be performed on day 15 of induction therapy and before each course of consolidation therapy to prevent central nervous system leukemia (CNSL). It is expected that about 55 patients will take part in this study.

Conditions

• Philadelphia-Positive ALL

Interventions

Type	Name	Description
DRUG	Olverembatinib	Given PO
DRUG	Prednisone	Given Intravenous
DRUG	Vincristine	Given Intravenous

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-09-30
• Completion: 2024-09-30
• First posted: 2022-07-20
• Last updated: 2022-09-01

Locations

1 site across 1 country: China