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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05466175
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2022
Completion date September 30, 2024

See also
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Recruiting NCT04475731 - Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse Phase 2
Not yet recruiting NCT05931757 - A Study of Olverembatinib Combined With Blinatumomab in the Treatment of Ph+ ALL Phase 2
Recruiting NCT06287528 - A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL) Phase 1
Recruiting NCT06220487 - A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL Phase 2
Not yet recruiting NCT06175702 - Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL