Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT
ConditionLeukemia, Myeloid, Acute
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSichuan University
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
KPS score > 60 or ECOG score 0-2;
The expected survival period > 3 months;
Received allo-HSCT and achieved complete remission (CR);
Disqualifiers
Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
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;
Poor graft function (PGF) occurred after allo-HSCT;
Trial design
Treatments tested in this trial
- Chidamide
Treatment groups
77 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov