Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Hospital
About this trial
To evaluate the efficacy and safety of Romiplostim N01 for platelet recovery after umbilical cord blood transplantation (UCBT) in patients with hematological malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥12 years old, male or female;
Patients diagnosed with hematological malignancies 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 Romiplostim N01;
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 design
Design model
Single group
Treatments tested in this trial
Romiplostim N01
DrugRomiplostim N01 was administered subcutaneously once weekly from +1 day to +28 days after UCBT at a recommended starting dose of 5µg/Kg (maximum single dose not to exceed 250µg) for a total of 4 administrations, with the option of continuation of dosing/switching/discontinuing after +28 days, depending on the patient's platelet profile.
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Romiplostim N01Experimental treatment 1 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
Time of platelet recovery
The Median time of platelet count ≥20×10\^9/L, 50×10\^9/L, 100×10\^9/L without platelet transfusions
Time frame
28 days3
Total platelet transfusion during 4 weeks of treatment
Total platelet transfusion during 4 weeks of treatment
Time frame
28 days4
Cumulative implantation rate of the granulocyte lineage at 28 days post-transplantation
Absolute neutrophil count (ANC) ≥0.5×10\^9/L for 3 consecutive days
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov