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

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

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.

Study Overview

• Status: Unknown
• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Eltrombopag
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Heamtology Department, Provincial Hospital Affiliated to Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients after allogeneic hematopoietic stem cell transplantation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The engraftment of platelet	the day of platelet engraftment	3 years
The levels of platelet	The levels of platelet at 30 days after transplantation	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of platelet transfusions	The number of platelet units be transfused to the patients before platelet engraftment	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The engraftment of white blood cell	The day of white blood cell engraftment	3 years
OS	3years overall survival of the patients	3 years

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital
• Investigators: Principal Investigator: Xin Wang, Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2019
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: March 30, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (ACTUAL): April 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SDPH001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No