Avatrombopag for Platelet Recovery Post-UCBT in Patients With Bone Marrow Failure Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorAnhui Provincial Hospital
About this trial
To evaluate the efficacy and safety of Avatrombopag for platelet recovery after unrelated cord blood transplantation (UCBT) in patients with bone marrow failure disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥12 years old, male or female;
Patients diagnosed with bone marrow failure disease including aplastic anemia (AA), Fanconi anemia (FA), paroxysmal nocturnal hemoglobinuria (PNH) and undergoing UCBT;
ECOG score ≤2;
Voluntary participation in this clinical trial, patients fully understand the trial content and sign the informed consent；
Disqualifiers
Pregnant or lactating women；
Known allergy to Avatrombopag;
A history of severe thrombotic events or known risk factors for thrombosis or active thromboembolism requiring anticoagulation;
A history of platelet dysfunction or bleeding prone disease or severe bleeding (requiring more than 2 units of red blood cell infusion or a hematocrit drop of ≥10%) within 7 days prior to screening;
Trial population
Patients diagnosed with bone marrow failure and receiving umbilical cord blood transplantation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Avatrombopag
DrugIndications for drug reduction and withdrawal: excluding blood transfusion factors, the reduction will be 20mg/d when PLT≥50×10\^9/L; Drug administration will be stopped when PLT≥100×10\^9/L.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Avatrombopag group1 intervention
Trial outcomes
Primary outcomes
1
Time of platelet engraftment
Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥20 × 10\^9/L.
Time frame
28 days2
The cumulative incidence of platelet engraftment at 28 days after transplantation
Platelet engraftment is defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥20 × 10\^9/L.
Time frame
28 daysSecondary outcomes
1
The cumulative incidence of platelet recovery rate at 28 days after transplantation
Platelet recovery was defined as independence from platelet transfusion for at least 7 days with a platelet count of more than ≥50×10\^9/L.
Time frame
28 days2
Total platelet transfusion during 4 weeks of treatment
Total platelet transfusion during 4 weeks of treatment
Time frame
28 days3
neutrophil reconstitution
neutrophil engraftment time was defined as the first of three consecutive days during which the neutrophil count was at least 0.5×10\^9/L.
Time frame
28 days4
erythroid reconstitution
RBC engraftment time was defined as the first day of achieving a reticulocyte count greater than 1% for 3 consecutive days.
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov