Hematological malignancies
Conditions
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old and = partial response (PR); 4. Before stem cell transplantation, it undergoes myeloablation pretreatment; 5. The infusion volume of CD34+ stem cells is greater than or equal to 2.0×10^6/Kg; 6. Hematopoietic stem cell complication Index (HCT-CI) <=1 point; 7.ECOG<=1 point; 8. Women of childbearing age should use contraception for at least one month before screening and commit to using contraception throughout the study period and continue until six months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Other TPO-RA platelet-generating drugs such as roprestine and eltrombopag have been used within 2 months before enrollment; 2. Combined with other diseases that cause thrombocytopenia, including ITP, MDS, AA, etc. 3. Those with a platelet count of less than 50×10^9/L before transplantation; 4. Patients with serious concomitant diseases that may interfere with the progress of clinical trials, such as renal failure requiring hemodialysis and active infections; 5. Those who have a history of symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebrovascular accident or transient ischemic attack, unstable angina pectoris or heart failure within the past 6 months; 6. Patients with thromboembolic diseases or those who developed thromboembolic diseases within half a year (not caused by interventional procedures); 7. Pregnant or lactating women; 8. During the research period, they were unwilling to adopt an effective contraceptive measure recognized by medicine; 9. Subjects who the researchers consider unsuitable to participate in the trial for other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days required for platelet implantation after roprestine N01 treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of platelet transfusions required and the total volume administered;Incidence of adverse reaction events;The number of days required for platelet recovery;The number of days required for neutrophil implantation; | — |
Countries
China
Contacts
Public ContactYanli Yang
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed