Status:
UNKNOWN
Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Safety and Efficacy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 de...
Detailed 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. Intrave...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04446806
Start Date
June 1 2019
End Date
May 31 2021
Last Update
June 25 2020
Active Locations (1)
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1
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China, 215000