refractory/recurrent thrombocytopenia
Conditions
Interventions
experimental group:interleukin-11 /TPO + Eltrombopag+MSC
control group:interleukin-11 /TPO + Eltrombopag
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) To be aged 18~80 years (including the cut-off value); (2) The expected survival time was no less than 2 months; (3) Performance status: Eastern Cooperative Oncology Group (ECOG) 0-5; (4) Diagnosed refractory / recurrent thrombocytopenia patients and meet one of the following conditions: At least one or more regimens such as hormone, interleukin-11, TPO, Eltrombopag and Chinese patent drug have failed to obtain a platelet value lower than 20 * 109 / L, or patients with early recurrence, multiple recurrence after platelet recovery or late recurrence after recovery of normal platelet, and failure to achieve complete remission after one course of standardized treatment; (5) The liver and kidney function, heart and lung function meet the following requirements: a) Creatinine was in the normal range; b) LVEF > 50%; c) Baseline blood oxygen saturation > 92%; d) Total bilirubin <= 2 times of upper limit of normal value, ALT and AST <= 2.5 times of upper limit of normal value; (6) Understand the experiment and have signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who are allergic to the above three drugs; (2) Patients who had malignant tumor except thrombocytopenia within 2 years before screening and were still in cancer treatment; (3) The Patients with positive HBsAg or HBcAb and HBV DNA titer >= 1 x 10^2 copies / L, HCV antibody positive and peripheral blood HCV RNA positive, human immunodeficiency virus (HIV) antibody positive, CMV DNA positive, syphilis positive, and so on; (4) Any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; (5) Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment; (6) Patients with pregnancy or lactation; (7) The central nervous system was invaded; (8) Other circumstance that obstructs the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of platelet count and function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and differentiation of megakaryocytes in bone marrow;Changes of lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactSong Guoqi
Affiliated Hospital of Nantong University
Outcome results
None listed