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Trial Title:
Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
NCT ID:
NCT05682755
Condition:
Leukemia, Myeloid, Acute
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Recurrence
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
initial time：platelet count ≥50×10^9/L after allo-HSCT initial dose: 5 mg oral twice
weekly initial adjustment: according to the platelet count tested weekly platelet count
≥50×10^9/L-increased by 5 mg 20×10^9/L≤ platelet count <50×10^9/L-remains unchanged
platelet count <50×10^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal
time: 180 days after allo-HSCT
Arm group label:
Chidamide
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
2. KPS score > 60 or ECOG score 0-2;
3. The expected survival period > 3 months;
4. Received allo-HSCT and achieved complete remission (CR);
5. Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10^9/L
for 3 consecutive days without G-CSF application, platelet count ≥ 20×10^9/L for 7
consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell
transfusion); and neutrophil count ≥ 1.5×10^9/L, platelet count ≥ 50×10^9/L within
45 days after transplantation;
6. No central nervous system involvement or clinical symptoms after transplantation;
7. Those who have no serious functional damage to important organs of the body;
8. Fully understand and be informed of this study and sign the ICF; willing to follow
and have the ability to complete all test procedures;
9. Females of childbearing age must afford a serum pregnancy test within 7 days before
the first dose, and the result should be negative; female participants and their
partners should agree to use effective contraception from signing the ICF until 6
months after the last dose.
Exclusion Criteria:
1. Serious basic diseases of important organs: such as myocardial infarction, chronic
cardiac insufficiency, decompensated hepatic insufficiency, renal function,
gastrointestinal insufficiency, etc.;
2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and
drug treatment is ineffective;
3. Participating in other clinical studies, or planning to start treatment in this
study and less than 4 weeks before the end of treatment in the previous clinical
study;
4. Poor graft function (PGF) occurred after allo-HSCT;
5. Combined with other malignant tumors and require treatment;
6. Active GVHD;
7. Have a history of allergy to Chidamide;
8. Pregnant or lactating females;
9. Patients with known history of human immunodeficiency virus (HIV) virus infection
and/or acquired immunodeficiency syndrome;
10. Patients with active chronic hepatitis B or active hepatitis C;
11. History of prolonged QT syndrome;
12. Patients considered by other researchers to be unsuitable for this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Ji, MD
Phone:
86-28-85422370
Email:
jieji@scu.edu.cn
Start date:
December 22, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05682755
