drugset
drugset / Trial / NCT04446806

Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia

NCT04446806 ↗

Phase 4 Unknown 100 enrolled The First Affiliated Hospital of Soochow University
NaSingle-groupSingle-blindTreatment

Summary

With the introduction of all-trans-retinoic acid (ATRA) and arsenic,the outcome of patients with acute promyelocytic leukemia (APL)has been improved considerably over the last decades.However，early deaths (EDs), mainly due to APL-specific coagulopathy, differentiation syndrome (DS)emerge as a major threat to APL patients.We observe and evaluate the effectivity of induction therapy in patients with APL. Administrate intravenous dexamethasone to prevent or preemptive treat DS. Assess the efficacy and safety of ruxolitinib as second treatment in patients with severe DS with no respond to dexamethasone.Furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.

Timeline

Start
2019-06-01
Primary completion
2020-12-31
Completion
2021-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 5 mg —
Subject Ruxolitinib Small molecule 20 mg —

Indications

No indication recorded.