The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Study Details
Study Description
Brief Summary
This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
With the progress of transplantation technology，allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treatment Group The patients will receive Eltrombopag treatment after transplantation at d1. |
Drug: Eltrombopag
The patients will receive Eltrombopag treatment after transplantation
|
| Control Group The patients will not receive Eltrombopag treatment after transplantation. |
Outcome Measures
Primary Outcome Measures
- The engraftment of platelet [3 years]
the day of platelet engraftment
- The levels of platelet [3 years]
The levels of platelet at 30 days after transplantation
Secondary Outcome Measures
- The number of platelet transfusions [3 years]
The number of platelet units be transfused to the patients before platelet engraftment
Other Outcome Measures
- The engraftment of white blood cell [3 years]
The day of white blood cell engraftment
- OS [3 years]
3years overall survival of the patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
-
Acceptance of allogeneic hematopoietic stem cell transplantation;
-
Voluntary acceptance of the study
Exclusion Criteria:
-
Patients with severe organ dysfunction or disease；
-
Patients who cannot tolerate oral Eltrombopag therapy;
-
Patients who refuse all-HSCT and Eltrombopag treatment;
-
Patients that investigator believed not suitable for enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heamtology Department, Provincial Hospital Affiliated to Shandong University | Jinan | Shandong | China | 250021 |
Sponsors and Collaborators
- Shandong Provincial Hospital
Investigators
- Principal Investigator: Xin Wang, Shandong Provincial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SDPH001