A review study to evaluate mannitol-assisted prophylaxis and treatment for acute promyelocytic leukemia

Completed

• Conditions: APL CNS relapse; Cancer; Acute promyelocytic leukaemia [PML]

• Registration Number: ISRCTN94954912
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Any age APL patients, with either risks of central nervous system (CNS) relapse or already diagnosed with CNS relapse
2. Patients agreed to receive the prophylaxis or treatment

Exclusion Criteria

1. Previous history of severe cardiovascular disease (coronary arterial disease, stroke, etc)
2. Severe chronic disease with poor prognosis (liver disease, kidney disease, etc)
3. Illegal drug use or chronic alcoholism
4. Physical limitations, mental or intellectual disabilities
5. Any condition that may affect the development of this trial

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Disease-free survival<br>2. Overall survival

Secondary Outcome Measures

Name	Time	Method
1. Cerebrospinal fluid (CSF) ATO concentrations<br>2. CSF tests of APL burden<br>3. Drug side effects evaluation