Delayed platelet engraftment after Allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
Test group:Romiplostim N01 for Injection treatment
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with hematological diseases undergoing allogeneic hematopoietic stem cell transplantation 2. Age: 18-80 years old; 3. ECOG score: 0-2 points; 4. Expected survival period>6 months; 5. Treatment without platelet receptor agonists (TPO-RA, rhTPO) and IL-11 after hematopoietic stem cell transfusion; 6. Healthy liver and kidney function (creatinine <= 1.5 × ULN, BUN <= 1.5 × ULN, ALT <= 2 × ULN, AST <= 2 × ULN, total bilirubin <= 1.5 × ULN); 7. Platelet count <= 20 × 10^9/L; 8. Bone marrow aspiration and cytogenetic examination within 6 days before the first use of loppromostim; 9. Willing to sign the informed consent form, can understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.Recurrence or progression of primary diseases in the blood system; 2.Uncontrolled acute graft-versus-host disease; 3.Patients who have received TPO-RA medication treatment for >= 7 days before treatment; 4.Uncontrollable active infections and other active malignant tumors that may interfere with research; 5.Suffering from New York Heart Association (NYHA) class III or IV heart failure, uncontrolled hypertension or hypotension, accompanied by a risk or event of thromboembolism; 6. The patient received anticoagulant therapy due to thrombotic events; 7. Patients who have an allergic reaction to the drugs or similar drugs used in this study; 8. Any other condition that, in the opinion of the investigator, the subject is not suitable to participate in the study; 9. Subject is currently enrolled in or has not completed 30 days since the end of other drug studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with platelet response during the treatment period (4 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with complete platelet response during the treatment period (4 weeks);Proportion of subjects with platelet response in the fourth week of treatment;Proportion of subjects who showed platelet response 4 weeks after discontinuation of medication;Incidence and severity of bleeding in subjects during treatment;Platelet transfusion frequency during treatment;Platelet transfusion volume during treatment;Proportion of subjects with erythroid and neutrophil responses during the treatment period (4 weeks);Time of first platelet response;The longest duration of platelet response and the total number of days for platelet response to meet the standard;Overall Survival; | — |
Countries
China
Contacts
Public ContactTong Hongyan
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed