Actively Recruiting
A Study of Chidamide With AZA in MRD Positive AML After Transplant
Led by Guangdong Provincial People's Hospital · Updated on 2023-10-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
C
Chipscreen Biosciences, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute myeloid leukemia (AML) is a cancer affecting the blood-forming system with diverse genetic characteristics. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the main treatment for AML, offering a potential cure. However, relapse occurs in 30% to 40% of patients after transplant, and this relapse is the leading cause of death in AML patients. This study aims to evaluate the combination of chidamide and azacitidine as a treatment for patients with minimal residual disease (MRD) positive AML before and after transplantation to reduce relapse rates and improve transplant outcomes. Participants receive chidamide orally at 10 mg daily from day 1 to day 6 each week for two weeks, followed by two weeks off, completing a 28-day cycle repeated for 12 cycles. Azacitidine is given by subcutaneous injection at 50 mg daily from day 1 to day 5 each week, also in 28-day cycles, for a total of 6 cycles. The study focuses on assessing the safety and effectiveness of this combined treatment in this patient group. During the study, researchers will monitor participants for relapse-free survival (RFS) at 6 months as the primary outcome. Secondary measures include MRD negativity rates, time to MRD negativity, 1- and 2-year RFS and overall survival (OS), graft-versus-host disease (GVHD) rates, and treatment-related adverse events over 24 months. Participants will undergo regular evaluations to track these outcomes and ensure safety throughout the study period, which continues until December 2026.
CONDITIONS
Brief Title
A Study of Chidamide With AZA in MRD Positive AML After Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with AML (excluding M3 subtype) who are MRD positive after allogeneic hematopoietic stem cell transplantation
- 18 years of age or older
- ECOG performance status of 3 or less
- Expected lifespan of 3 months or more
- Agree to use contraceptive measures
- Signed informed consent
You will not qualify if you...
- Allergy to the study drugs
- Gastrointestinal conditions preventing oral medication
- Active infection at the time of screening
- Dysfunction of vital organs
- Presence of other malignancies
- HIV infection
- Hepatitis B or C infection
- Prolonged QT interval on ECG
- Pregnant or lactating women
- Currently enrolled in other clinical studies
- Investigator's judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 months
Participants receive chidamide orally for two weeks followed by two weeks rest per cycle, repeated for 12 cycles, and azacitidine by subcutaneous injection for 5 days each cycle, repeated for 6 cycles.
Weekly visits during treatment cycles
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
W
WENG jian yu, M.D.
L
Ling Wei, M.D.
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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