drugset / Trial / NCT06087419

A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Venetoclax in RR Ph-ALL and B-cell Lymphoma Patients

NCT06087419

NaSingle-groupOpen-labelTreatment

Summary

This study is a multicenter, prospective, interventional clinical trial aimed at recruiting relapsed/refractory Ph-ALL patients at multiple stem cell transplantation centers, including the Stem Cell Transplantation Center of the Chinese Academy of Medical Sciences Hematology Hospital. The anticipated enrollment is 42 subjects. The enrolled patients are planned to receive a treatment regimen of chidamide in combination with venetoclax and obinutuzumab. Patients who achieve remission will undergo allogeneic stem cell transplantation, followed by continued oral maintenance therapy with chidamide for one year post-transplantation based on the disease condition.

Timeline

Start
2023-10-30
Primary completion
2024-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Inotuzumab Ozogamicin Monoclonal antibody 0.6 mg/m2
Subject Tucidinostat Small molecule 10 mg Oral
Subject Venetoclax Small molecule 400 mg Oral