Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18
Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
ECOG：0-2
Life expectancy ≥ 3 months
Disqualifiers
Diagnosis of acute promyelocytic leukemia (APL)
Central nervous system leukemia
Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
Trial design
Design model
Single group
Treatments tested in this trial
venetoclax combining chidamide and azacitidine (VCA)
Druginformation already included in arm/group descriptions
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: venetoclax combining chidamide and azacitidine (VCA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete remission (CR) rate
CR was \<5% marrow blasts by morphology
Time frame
2 months2
Overall response rate (ORR)
ORR is defined as CR, CRi and PR.
Time frame
2 monthsSecondary outcomes
1
1 year leukemia free survival (LFS)
Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation
Time frame
1 year from treatment initiation2
1year overall survival (OS)
Overall survival（OS）is defined as the time from treatment initiation to death from any cause.
Time frame
1 year from treatment initiation3
Adverse events
Adverse event is defined as any untoward medical occurrence associated with treatment
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Xiamen University
Lead sponsor
Fujian Provincial Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Zhangzhou manicipal hospital of Fujian Province
Collaborator
Jieyang People's Hospital
Collaborator
Dongguan People's Hospital
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Source ClinicalTrials.gov