Status:
UNKNOWN
Eltrombopag For Secondary Poor Graft Function Post Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Poor Graft Function
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 ra...
Detailed Description
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 morb...
Eligibility Criteria
Inclusion
- 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
- 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.
- Eastern Cooperative Oncology Group(ECOG) performance status≥2.
- Patients with a birth plan within 1 years, the pregnant or lactating women.
- 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.
- Patients with cataract history；
- Patients with myelofibrosis;
- Patients who are unable to comply in the test and / or follow up stage.
- Any abnormal situation in the screening stage or any other medical history or status that the researchers think is not suitable for the study.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03437603
Start Date
February 1 2018
End Date
January 1 2020
Last Update
February 19 2018
Active Locations (1)
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1
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China