The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT

• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Eltrombopag
• Interventions: Drug: Eltrombopag

• Registration Number: NCT03902041
• Lead Sponsor: Shandong Provincial Hospital

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.

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-30
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-03
• Last Update Posted: 2019-04-03
• Study Start: 2019-05-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
2. Acceptance of allogeneic hematopoietic stem cell transplantation;
3. Voluntary acceptance of the study

Exclusion Criteria

1. Patients with severe organ dysfunction or disease；
2. Patients who cannot tolerate oral Eltrombopag therapy;
3. Patients who refuse all-HSCT and Eltrombopag treatment;
4. Patients that investigator believed not suitable for enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	Eltrombopag	The patients will receive Eltrombopag treatment after transplantation at d1.

Primary Outcome Measures

Name	Time	Method
The levels of platelet	3 years	The levels of platelet at 30 days after transplantation
The engraftment of platelet	3 years	the day of platelet engraftment

Secondary Outcome Measures

Name	Time	Method
The number of platelet transfusions	3 years	The number of platelet units be transfused to the patients before platelet engraftment

Trial Locations

Locations (1)

Heamtology Department, Provincial Hospital Affiliated to Shandong University; 🇨🇳 Jinan, Shandong, China