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

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03902041
• Other study ID #: SDPH001
• Status: Not yet recruiting
• Start date: May 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2019
• Source: Shandong Provincial Hospital
• Contact: Xiaosheng Fang
• Phone: 15168889703
• Email: fxsh_1010[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: October 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation
• Eltrombopag

Intervention

Drug:
• Eltrombopag
The patients will receive Eltrombopag treatment after transplantation

Locations

Country	Name	City	State
China	Heamtology Department, Provincial Hospital Affiliated to Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The engraftment of white blood cell	The day of white blood cell engraftment	3 years
Other	OS	3years overall survival of the patients	3 years
Primary	The engraftment of platelet	the day of platelet engraftment	3 years
Primary	The levels of platelet	The levels of platelet at 30 days after transplantation	3 years
Secondary	The number of platelet transfusions	The number of platelet units be transfused to the patients before platelet engraftment	3 years