drugset / Trial / NCT05026229

A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL

NCT05026229

RandomizedParallel-groupOpen-labelTreatment

Summary

This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi'an Jiaotong University. Tyrosine kinase inhibitors (TKI) combined with intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.

Timeline

Start
2021-09-06
Primary completion
2023-06-30
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule
Subject Methotrexate Small molecule
Subject Prednisone Other / unclassified
Subject Vincristine Small molecule
Background dasatinib anhydrous Small molecule