Avapritinib Maintenance for AML With KIT Mutations
ConditionAML, Adult
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorRuijin Hospital
About this trial
A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥ 14 years old;
First allo-HSCT for AML (including secondary AML) ;
KIT mutation at diagnosis (no restriction on locus for kit mutation
CR and negative MFC-MRD prior to initiation of maintenance therapy;
Disqualifiers
concurrently receiving other targeted therapies for AML;
Prior treatment with a TKI inhibitor that proved ineffective;
with concurrent FLT3-ITD mutations at enrollment;
Acute/chronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy;
Trial design
Design model
Single group
Treatments tested in this trial
Avapritinib
DrugAfter allo-HSCT, CBF-AML patients who have kit mutation would receive avapritinib for maintenance therapy.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative incidence of relapse
disease relapse
Time frame
through study completion, an average of 2 yearSecondary outcomes
1
Overall survival
death as a result of any causes
Time frame
through study completion, an average of 2 year2
Non relapse mortality
death without disease progression or relapse
Time frame
through study completion, an average of 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: