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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT04446806
Phase
PHASE4
Status
Unknown

Conditions

  • Safety and Efficacy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib as second treatment in patients with severe DS failed in responding to hormone.Furthermore

Study Details

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.

Key Dates

Start date
Jun 1, 2019
Status verified
Mar 2020
Primary completion
Dec 31, 2020
Completion
May 31, 2021

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

complete remission rate [ Time Frame: during the induction treatment ]

Central Contacts