Phase III Study of LP-118 with Ponatinib, Vincristine, and Dexamethasone for Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

What this Trial Is About

Researchers are studying an experimental drug called LP-118 to understand its side effects and find safe doses. This study also aims to see if LP-118 can be safely combined with ponatinib, an FDA-approved medicine for acute lymphoblastic leukemia. The trial focuses on patients with relapsed or refractory T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma. Participants will receive LP-118 and ponatinib together in increasing or decreasing doses to find the highest safe dose. They will also get standard chemotherapy with vincristine, dexamethasone, and methotrexate. Treatments are given in 21-day cycles, with LP-118 and ponatinib taken daily at home. The first cycle includes seven study visits, while subsequent cycles have five visits each. During the study, participants will have regular visits for monitoring, lab tests, and assessments. Researchers will evaluate safety and determine recommended doses over 36 weeks. They will also measure remission rates, survival, and disease progression. The study includes informed consent, organ function checks, and contraception requirements. Participation lasts through treatment cycles with ongoing safety monitoring.

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)