Actively Recruiting
Optimum Induction Therapy of Low-risk APL
Led by Peking University People's Hospital · Updated on 2024-05-10
74
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Despite the high cure probability for acute promyelocytic leukemia (APL), a minority of patients will relapse and the risk factors for relapse are unclear. The goal of this clinical trial is to compare the effectiveness and safety of induction of oral all-trans retinoic acid (ATRA) and realgar-indigo naturalis formula (RIF) combined with oral etoposide or daunorubicin as cytoreductive therapies in low-risk APL. The present study was to explored a cytoreduction of an oral etoposide for low-risk APL with dual induction of ATRA and RIF as a high efficacy, low recurrence, and more convenient all-oral regimen.
CONDITIONS
Official Title
Optimum Induction Therapy of Low-risk APL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed APL patients according to WHO 2008 diagnostic classification
- Aged between 18 and 75 years
- Liver function tests: ALT and AST no more than 2.5 times upper limit of normal, bilirubin no more than 2 times upper limit of normal
- Renal function: muscle salt (creatinine) no more than 3 times upper limit of normal
- Physical strength score (ECOG) between 0 and 2
- White blood cell count no greater than 10 x 10^9/L
- Signed informed consent form
You will not qualify if you...
- Participation in other clinical trials within the past 30 days
- Pregnant or breastfeeding
- Positive HIV serological test
- Positive viral hepatitis serological test
- Severe arrhythmia or abnormal electrocardiogram (QT interval greater than 500 ms)
- Mental illness or inability to cooperate with treatment and monitoring
- Participation in other clinical research simultaneously
- Failure to sign informed consent form
- Other conditions deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Institute of Hematology
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
X
Xiaolu Zhu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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