Cancer treatment-related thrombocytopenia
Conditions
Interventions
Treatment Group:Romiplostim N01
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eligible patients have either: 1) newly diagnosed acute leukemia (e.g., AML, ALL, or MPAL) confirmed cytologically and having achieved remission (marrow blasts = 2.0 × 10?/L Hemoglobin (Hb) >= 8.0 g/dL Platelet count >= 100 × 10?/L; Hepatic Function: Total bilirubin = 50 mL/min. 6. For women of childbearing potential,highly effective contraception is required for the duration of the study;
Exclusion criteria
Exclusion criteria: 1. Patients with missing or incomplete relevant clinical data from the prior intensive therapy. 2. Use of thrombopoiesis-stimulating agents has been documented during the last intensive treatment cycle; 3. Prolonged myelosuppression (>28 days to recover to ANC >=1.5×10?/L or platelets >=50×10?/L) following prior therapy. 4. Concurrent myelofibrosis, or a documented history of aplastic anemia, myelodysplastic syndrome (MDS), paroxysmal nocturnal hemoglobinuria (PNH), primary myelofibrosis (PMF), polycythemia vera (PV), essential thrombocythemia (ET), or congenital bone marrow failure syndromes. 5. Presence of active bleeding. 6. Active serious infection requiring therapeutic intervention with systemic medication. 7. History of arterial or venous thromboembolism within 6 months prior to screening. 8. Uncontrolled or clinically significant cardiovascular disease, as evidenced by any of the following at screening: • Congestive heart failure • Unstable angina • Myocardial infarction • Primary cardiomyopathy • Arrhythmia requiring medical intervention • Left ventricular ejection fraction (LVEF) <50%; 9. Female subjects who are pregnant or lactating. 10. Any other condition that, in the investigator’s opinion, would render the subject an unsuitable candidate for the study, such as poor adherence, significant psychiatric condition, potential for delayed hematologic recovery due to extensive prior therapy, other contraindications to intensive treatment, or enrollment in another interventional trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Platelet Recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and total volume of platelet transfusions;Minimum and maximum platelet values; | — |
Countries
China
Contacts
Public ContactFang Zhihong
The First Affiliated Hospital of Xiamen University
Outcome results
None listed