primary immune thrombocytopenia
Conditions
Interventions
trial group:Vinblastine-loaded platelet suspension (PLT-VDS): intravenous infusion, 2-3×109/L PLT (100 ml, VDS 3mg/m2) /w×(4-6w)
rhTPO: 300 U/kg, subcutaneous injection, 1 time/d × 14 d. Discontinue rhTPO if platelet count =100×109/L or absolute value of platelet count elevation =50×109/L in less than 14 days.
control group:rhTPO: 300 U/kg, subcutaneous injection, 1 time/d × 14 d. Discontinue rhTPO if platelet count =100×109/L or absolute value of platelet count elevation =50×109/L in less than 14 days.
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18~80 years old, male or female; 2) Subjects with a confirmed diagnosis of chronic primary immune thrombocytopenia (duration =12 months) and a mean of 2 platelet counts 35×109/L). In addition, peripheral blood smear results should support the diagnosis of ITP without evidence indicating other etiologies of thrombocytopenia (e.g., pseudothrombocytopenia, myelofibrosis). Physical findings should not indicate any condition other than ITP that may cause thrombocytopenia; 3) Subjects who have received 1 or more prior treatments for ITP (including, but not limited to, glucocorticoids, immunoglobulins, azathioprine, danazol, cyclophosphamide, and/or rituximab); 4) Subjects must have had a response to one prior ITP therapy (platelet count >50 x 109/L) or have a bone marrow examination consistent with ITP within 3 years in order to rule out myelodysplastic syndromes (MDS) or other etiologies of thrombocytopenia; 5) Prothrombinogen time not exceeding ±3s of the normal range (or international normalized ratio must be within 80% to 120% of the normal range), activated partial thromboplastin time not exceeding ±10s of the normal range, and no history of hypercoagulable state; 6) Last routine blood test during the screening period: hemoglobin = 100 g/L and absolute neutrophil count (ANC) = 1.5 x 10^9/L; 7) Voluntary acceptance of treatment and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1) those who are pregnant or breastfeeding 2) those with a history of thrombosis 3) severe cardiopulmonary, hepatic or renal abnormalities; 4) Severe or uncontrollable infections; 5) HCV, HBV, HIV carriers or patients. 6) History of mental illness; 7) Contraindications to the use of vincristine and TPO; 8) have received a platelet transfusion, TPO, or vincristine within 1 week prior to randomization. 9) any other condition that, in the opinion of the investigator, makes it inappropriate for the patient to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time when platelets start to rise; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and quantity of platelet transfusions;treatment efficacy;safety;total medical costs;change in bleeding score; | — |
Countries
China
Contacts
Public ContactXu Peipei
Department of Hematology, Drum Tower Hospital, Nanjing
Outcome results
None listed