Combining Chidamide and Azacitidine for AML Treatment After Transplant
A Study of Chidamide With AZA in MRD Positive AML After Transplant
This study is testing if combining two drugs, Chidamide and azacitidine, can help people with acute myeloid leukemia who still have some cancer after a stem cell transplant to stay cancer-free longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06066905 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Chidamide in combination with azacitidine for patients with minimal residual disease (MRD) positive acute myeloid leukemia (AML) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The goal is to reduce the recurrence rate of AML after transplantation and improve overall treatment outcomes. The study will assess both the efficacy and safety of this combined treatment approach in eligible patients. Participants will be monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with MRD-positive AML after undergoing allo-HSCT.
Not a fit: Patients with active infections, other malignancies, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly lower the risk of AML relapse after transplantation, potentially improving survival rates for patients.
How similar studies have performed: While the combination of Chidamide and azacitidine is a novel approach, similar studies targeting MRD in AML have shown promising results in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: WENG jian yu, M.D. — Department of Hematology, Guangdong Provincial People's Hospital
- Study coordinator: WENG jian yu, M.D.
- Email: wengjianyu1969@163.com
- Phone: 020-83827812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.