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

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.