Eltrombopag For Secondary Poor Graft Function Post Allogeneic Hematopoietic Stem Cell Transplanta… (NCT03437603) | Clinical Trial Compass
UnknownPhase 2
Eltrombopag For Secondary Poor Graft Function Post Allogeneic Hematopoietic Stem Cell Transplantation
China20 participantsStarted 2018-02
Plain-language summary
To investigate the efficacy and safety for secondary poor graft function (PGF) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary objective is the hematologic response rate. Secondary objectives include: (1) incidence and severity of adverse events; (2) overall survival (OS), and disease-free survival(DFS).
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Patients develop poor graft function post allo-HSCT(primary or secondary),who had no response or were transfusion dependent after clinical therapeutic approaches(including growth factors,MSC transfusion,Cluster of differentiation(CD34) positive selected tem cell boosts infusion et al)
✓. No recurrence or progression of primary malignancy after allo- HSCT
✓. Patients with full donor chimerism
✓. Patients without severe GVHD or active infectious diseases, or drug-related myelosuppression;
✓. Written informed consent obtained from the subject.
Exclusion criteria
✕. Alanine aminotransferase(ALT)≥2.5 times the upper limit of normal(ULN)
✕. Serum bilirubin \>2mg/dl
✕. History of hepatic cirrhosis or the history of portal hypertension
✕. Patients had any history of arterial / venous thrombosis within 1 year before enrollment in the study.
✕. Take another treatment for drugs in 30 days or five half-life (no matter which longer) before the first drug delivery.
. History of heart disease in the last 3 months, including congestive heart failure(III/IV Level, NHYA) ,arrhythmia, or myocardial infarction which medication is necessary. Any arrhythmia which could increase the risk of thrombotic events, or extended QT interval (QTc) of \>480 milliseconds after correction.