Actively Recruiting
Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
Led by Sichuan University · Updated on 2023-01-12
77
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT. Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.
CONDITIONS
Official Title
Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at the time of signing consent
- KPS score greater than 60 or ECOG score between 0 and 2
- Expected survival longer than 3 months
- Received allogeneic hematopoietic stem-cell transplantation (allo-HSCT) and achieved complete remission
- Hematopoietic recovery with neutrophil count at least 0.5 x 10^9/L for 3 days without G-CSF, platelet count at least 20 x 10^9/L for 7 days without transfusion, hemoglobin at least 80 g/L without transfusion; and neutrophil count at least 1.5 x 10^9/L and platelet count at least 50 x 10^9/L within 45 days post-transplant
- No central nervous system involvement or symptoms after transplantation
- No severe functional damage to major organs
- Understand and agree to the study procedures and sign informed consent
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during the study and for 6 months after last dose
You will not qualify if you...
- Serious diseases affecting major organs such as myocardial infarction, chronic heart failure, decompensated liver failure, renal or gastrointestinal failure
- Uncontrolled active infections including bacterial, fungal, or viral infections unresponsive to treatment
- Currently participating in other clinical trials or within 4 weeks of completing another study
- Poor graft function after allo-HSCT
- Having other active malignant tumors requiring treatment
- Active graft-versus-host disease (GVHD)
- Allergy history to chidamide
- Pregnant or breastfeeding women
- Known HIV infection or AIDS
- Active chronic hepatitis B or C infection
- History of prolonged QT syndrome
- Considered unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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