AML, Adult, Minimal Residual Disease
Conditions
Brief summary
acute myeloid leukemia (AML) is a malignant tumor of the hematopoietic system with high heterogeneity in cytogenetics and molecular biology.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the primary treatment option for patients with AML and the most effective method for radical treatment of AML.Despite considerable progress in allo-HSCT over the past decade, 30%-40% of patients still relapse, and post-transplant relapse remains the leading cause of death in patients with AML.
Detailed description
Investigators proposed Chidamide combined with azacitidine as the prospective treatment for MRD-positive AML patients before and after transplantation, hoping to reduce the recurrence rate of transplantation and improve the transplantation effect. The efficacy and safety of the method will be verified by this clinical study.
Interventions
DRUGchidamide and azacitidine
chidamide：10mg orally,day 1 to day 6 every week, Take it for two weeks, rest for two weeks,so 28 days for a circle, 12 circles totally. azacitidine:50mg,subcutaneous injection,day 1 to day 5 every week, 28 days for a circle, 6 circles totally.
Sponsors
Shenzhen Chipscreen Biosciences Co.Ltd
Guangdong Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with AML (diagnostic criteria refer to WHO2016 criteria, except M3) can detect small residual lesions (MRD) positive after allogeneic hematopoietic stem cell transplantation (allo-HSCT); 2. ≥18 years old; 3. ECOG≤3; 4. lifespan≥3 months; 5. Take contraceptive measures; 6. Sign informed consent.
Exclusion criteria
1. Allergic to the study drug; 2. A gastrointestinal condition that prevents oral medication; 3. active infection; 4. Dysfunction of vital organs; 5. other malignancies; 6. HIV infection; 7. HBV or HCV; 8. The QT interval is prolonged; 9. Pregnant or lactating women; 10. Is participating in other clinical studies; 11. The researchers did not consider it appropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of RFS in 6 months | 6 months | relapse-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rate of MRD turn negative in 6 months | 6 months | minimal residual disease turn negative |
| the time length of MRD negative | 24 months | minimal residual disease negative |
| the 1 year/2 year RFS | 24 months | relapse-free survival |
| the rate of GVHD | 24 months | graft-versus-host disease |
| Incidence of Treatment-Emergent Adverse Events | 24 months | Grade 1 to Grade 4 ,according to Common Terminology Criteria for Adverse Events, versions 5.0 |
| the 1 year/2 year OS | 24 months | overall survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| T cell receptor excision circles (TRECs) level before and after treatment | 24 months | T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor. |
| the rate of MRD turn negative in molecular genetic abnormality subtype | 24 months | minimal residual disease |
Countries
China
Contacts
Primary ContactWENG jian yu, M.D.
Backup ContactLing Wei, M.D.
Outcome results
None listed