Poor platelet engraftment after hematopoietic stem cell transplantation, either primary or secondary
Conditions
Interventions
Experiment group:The subjects were subcutaneously injected with ropivacaine at an initial dose of 3 µg/kg. During the injection process, the dose could be adjusted according to the platelet count unti
Sponsors
Huaian Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 70 years old, both genders are eligible; 2. Primary engraftment failure after autologous or allogeneic hematopoietic stem cell transplantation (neutrophil and platelet counts have not reached the standard for hematopoietic reconstitution at 28 days after transplantation) or secondary engraftment failure (ANC < 0.5×10^9/L and PLT < 20×10^9/L persistently after hematopoietic reconstitution, accompanied by loss of donor chimerism or no relapse with donor chimerism rate < 5% in the bone marrow); 3. The investigator determines that the patient can receive romiplostim administration; 4. No severe underlying diseases; 5. No severe active infections. ; 6. ECOG score ranging from 0 to 2; 7. Expected survival period longer than 6 months.
Exclusion criteria
Exclusion criteria: 1. Those who have received TPO-RA treatment within 30 days; 2. Patients with any recurrent malignant tumors; 3. Patients with uncontrollable active infections; 4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5xULN; 5. Total bilirubin > 2xULN; 6. According to the National Institutes of Health criteria, classified as grade III-IV acute graft-versus-host disease or severe chronic graft-versus-host disease; 7. Have experienced severe thrombotic events, or known risk factors for thrombosis. Exceptions: Subjects whose potential benefits from participating in the study outweigh the potential risks of thromboembolic events as determined by the investigators. 8. Had heart diseases within 6 months before screening, such as congestive heart failure with NYHA classification III/IV, angina pectoris, myocardial infarction and arrhythmias requiring treatment; 9. Had long QT syndrome during screening; 10. Had active hepatitis B or hepatitis C; 11. Positive for anti-human immunodeficiency virus antibody or anti-treponema pallidum antibody; 12. Pregnant or lactating women; 13. Subjects judged by the investigators to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet engraftment time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival ;Overall survival;Neutrophil implantation time;Safety; | — |
Countries
China
Contacts
Public ContactYanming Zhang
Huaian Second People's Hospital
Outcome results
None listed