NCT05270200 Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse
| NCT ID | NCT05270200 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Zhujiang Hospital |
| Condition | Leukemia, Myeloid, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-02-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.
Eligibility Criteria
Inclusion Criteria: * 1.Age 18 to 60 years old,both male and female * 2.Be able to understand and sign informed consent * 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic * 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML * 5.Patients with an ECOG performance status 0,1,2 or 3 * 6.Expected survival time ≥ 3 months * 7.Non-hematological toxicity related to transplantation does not exceed Grade 2 * 8.Laboratory indicators meet the following standards: 1. 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal. 2. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment. 3. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion. 4. Serum creatinine clearance rate is greater than 30ml/min. Exclusion Criteria: * 1.Uncontrollable active infection * 2.Patients with active hepatitis B or C or HIV infection before enrollment * 3.Have a grade III-IV graft-versus-host disease
Contact & Investigator
Rui Huang, Doctor
PRINCIPAL INVESTIGATOR
Zhujiang Hospital
Frequently Asked Questions
Who can join the NCT05270200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Leukemia, Myeloid, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05270200 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05270200 currently recruiting?
Yes, NCT05270200 is actively recruiting participants. Contact the research team at Rachelchn@163.com for enrollment information.
Where is the NCT05270200 trial being conducted?
This trial is being conducted at Guanzhou, China.
Who is sponsoring the NCT05270200 clinical trial?
NCT05270200 is sponsored by Zhujiang Hospital. The principal investigator is Rui Huang, Doctor at Zhujiang Hospital. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.