A Study of Chidamide With AZA in MRD Positive AML After Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
≥18 years old;
ECOG≤3;
lifespan≥3 months;
Disqualifiers
Allergic to the study drug;
A gastrointestinal condition that prevents oral medication;
active infection;
Dysfunction of vital organs;
Trial design
Design model
Single group
Treatments tested in this trial
chidamide and azacitidine
Drugchidamide：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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: chidamide and azacitidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the rate of RFS in 6 months
relapse-free survival
Time frame
6 monthsSecondary outcomes
1
the rate of MRD turn negative in 6 months
minimal residual disease turn negative
Time frame
6 months2
the time length of MRD negative
minimal residual disease negative
Time frame
24 months3
the 1 year/2 year RFS
relapse-free survival
Time frame
24 months4
the 1 year/2 year OS
overall survival
Time frame
24 monthsOther outcomes
1
T cell receptor excision circles (TRECs) level before and after treatment
T cell receptor excision circles (TRECs) are released upon rearrangement of the T cell receptor.
Time frame
24 months2
the rate of MRD turn negative in molecular genetic abnormality subtype
minimal residual disease
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Guangdong Provincial People's Hospital
Lead sponsor
Chipscreen Biosciences, Ltd.
Collaborator
Source ClinicalTrials.gov