rhTPO + CsA vs CsA in the Treatment of LR-MDS With Thrombocytopenia

rhTPO + CsA Versus CsA Alone in the Treatment of Lower-risk MDS With Thrombocytopenia: a Single-center Randomized Controlled Trial

This study aims to compare the efficacy and safety of recombinant human thrombopoietin (rhTPO) + cyclosporine (CsA) and CsA monotherapy in the treatment of lower-risk myelodysplastic neoplasms with thrombocytopenia.

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Confirmed diagnosis of lower-risk MDS;
3. Platelet ≤ 30×109/L, or < 50×109/L and accompanied by bleeding events;
4. Baseline liver and kidney functions <2 ULN;
5. Signed the informed consent form;
6. ECOG 0-2;

Exclusion Criteria:

1. History of leukemia or stem cell transplantation, treatment-related MDS or malignant tumors;
2. With splenomegaly or myelofibrosis;
3. Infections or bleeding that cannot be controlled by standard treatment;
4. Any concurrent malignant tumors within the past 5 years, or basal cell carcinoma of the skin at the local site;
5. History of thromboembolic events, heart attack or stroke and current use of anticoagulants;
6. Previously received cyclosporine (CsA) or ATG within 6 months;
7. Previously used IL-11, rhTPO or TPO-RA;
8. Pregnant or lactating women;
9. Participated in other clinical trials within 3 months.