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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    100
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 24 January 2021

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.Howeverearly 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.Furthermorethe changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of DS.

Description

Adults ages 18-75 with primary acute promyelocytic leukemia.

Design

The induction therapy with ATRA 25mg/m2/d and ATO 10mg/kg/d should be started as soon as the diagnosis of APL confirmed.

Intravenous dexamethasone at a dose of 5-20 mg daily must be started if the WBC count greater than 5e+9/L (before or during the treatment with ATRA) as prevention or preemptive therapy of DS.

Idarubicin (4-10 mg/m2 /d*3d) and hydroxyurea1.0-3.0g/dcan be given as leukocyte lowering therapy which may lessen the risk of DS.

When the progression of clinical symptoms of DS with no response to dexamethasone,ATRA must be stopped and ruxolitinib (5-20mg /d) should be administrated to reduce the production of cytokines.

Participants should stay in the hospital during the treatment for about 4 weeks.

The changes of spectrum of cytokines are monitored to discover the potential relationship between the cytokines and the severity of DS.

Participants will visit every 1 months after CR for 3 years.

Details
Condition Safety and Efficacy
Treatment Ruxolitinib
Clinical Study IdentifierNCT04446806
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Safety and Efficacy?
Do you have any of these conditions: Do you have Safety and Efficacy??
Clinical diagnosis of primary acute promyelocytic leukemia
ECOG score3
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
Clear my responses

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