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

• Status: Recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University

Criteria

Inclusion Criteria:

• Clinical diagnosis of primary acute promyelocytic leukemia.

• ECOG score≤3.

• Must be able to understand and willing to participate in the study and sign the informed consent.

Exclusion Criteria:

• Refractory/secondary acute promyelocytic leukemia.

• Severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc.

• Clinically uncontrolled active infections.

• Malignant tumors with other progresses.

• Ecg: QT interval > 450 ms.

• Allergic to arsenic agent.

• Pregnant or lactating women.