drugset / Trial / NCT03642236

Combination of BTK Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant AML

NCT03642236

Phase 2/3 Unknown 122 enrolled Nanfang Hospital, Southern Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML. BTK is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, the efficacy and safety of combination of BTK inhibitor with chemotherapy with/without FLT3 inhibitor in refractory/relapsed FLT3 mutant AML are evaluated.

Timeline

Start
2018-08
Primary completion
2022-08
Completion
2023-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg