About this trial
Evaluation of the efficacy and safety of recombinant human thrombopoietin (rhTPO) at 300 U/kg/day for hematopoietic stem cell mobilization in autologous transplantation among acute leukemia patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18~65 years, regardless of gender.
Histopathologically confirmed acute leukemia with immunohistochemical validation
Sustained complete hematologic remission with documented minimal residual disease (MRD) negativity.
Eastern Cooperative Oncology Group (ECOG) performance status smaller than 2 and a life expectancy of more than 6 months
Disqualifiers
Liver dysfunction (alanine aminotransferase or bilirubin greater than two times the normal upper limit).
Renal dysfunction (creatinine or urea higher than 1.5 times the normal upper limit).
Any disease that could put patients at high risk, including but not limited to unstable cardiac disease, uncontrolled atrial fibrillation or hypertension, severe diabetic retinopathy
rhTPO aller- gies.
Trial design
Single group
Treatments tested in this trial
Recombinant Human Thrombopoietin(rhTPO)
DrugG-CSF will be administered at a dose of 10 μg/kg/day subcutaneously for 7-10 days post-chemotherapy. rhTPO is started on the same day as G-CSF at 300 U/kg/d and injected subcutaneously until the stem cell collection was completed.
Treatment groups
Trial outcomes
Primary outcomes
total CD34+ cell count
Median total number of CD34+ cells collected
Secondary outcomes
the proportion of patients collecting more than or equal to 2*10^6 CD34+ cells/kg
the proportion of patients collecting more than or equal to 5*10^6 CD34+ cells/kg
total mononuclear cell count
Median total number of mononuclear cells collected
time of platelet engraftment
defined as platelet count \>20×109 platelets/L for seven consecutive days without platelet transfusion
Sponsors and contacts
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