Eltrombopag For Secondary Poor Graft Function Post Allogeneic Hematopoietic Stem Cell Transplantation

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Feb 11, 2018

Keywords

ClinConnect Summary

Poor graft function (PGF) remains a life-threatening complication that occurs in 5-27% of patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT), and is associated with morbidity and mortality related to infections or hemorrhagic complications.

PGF is defined below: (1) with two or three cytopenic lines (hemoglobin ≤70 g/L, neutrophil count ≤0.5×109/L, platelet count ≤20×109/L) with transfusion requirements; (2) with hypoplastic bone marrow and full donor chimerism; (3) without relapse or severe graft versus host diseases(GVHD) or active infectious diseases, or d...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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)
• • 2. No recurrence or progression of primary malignancy after allo- HSCT
• • 3. Patients with full donor chimerism
• • 4. Patients without severe GVHD or active infectious diseases, or drug-related myelosuppression;
• • 5. Written informed consent obtained from the subject.
• Exclusion Criteria:
• • 1. Alanine aminotransferase(ALT)≥2.5 times the upper limit of normal(ULN)
• • 2. Serum bilirubin \>2mg/dl
• • 3. History of hepatic cirrhosis or the history of portal hypertension
• • 4. Patients had any history of arterial / venous thrombosis within 1 year before enrollment in the study.
• • 5. Take another treatment for drugs in 30 days or five half-life (no matter which longer) before the first drug delivery.
• • 6. Eastern Cooperative Oncology Group(ECOG) performance status≥2.
• • 7. Patients with a birth plan within 1 years, the pregnant or lactating women.
• • 8. 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.
• • 9. Patients with cataract history；
• • 10. Patients with myelofibrosis;
• • 11. Patients who are unable to comply in the test and / or follow up stage.
• • 12. Any abnormal situation in the screening stage or any other medical history or status that the researchers think is not suitable for the study.