Viewing Study NCT05961410



Ignite Creation Date: 2024-05-06 @ 7:19 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05961410
Status: RECRUITING
Last Update Posted: 2024-01-02
First Post: 2023-07-09

Brief Title: Eltrombopag for Peripheral Blood Stem Cell Harvest
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Eltrombopag Plus G-CSF for Human CD34 Cell Mobilization in Patients With Lymphoma Undergoing Autologous Stem Cell Harvest
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EPBSCH
Brief Summary: The goal of this clinical trial is to explore the activity of eltrombopag in lymphoma patients receiving autologous hematopoietic stem cell harvest The main questions it aims to answer are

Determine the efficacy of adding eltrombopag during autologous hematopoietic stem cell mobilization and harvest
Determine the pharmacokinetics and pharmacodynamics of serum eltrombopag concentration circulating CD34 cells during autologous hematopoietic stem cell mobilization

Participants will receiving additional eltrombopag during stem cell harvest procedure The amount of harvested stem cells will be compared with historical group to see if eltrombopag could increase the amount of harvested stem cells
Detailed Description: Autologous hematopoietic stem cell transplantation auto-HSCT is the standard treatment for many malignant diseases including plasma cell myeloma lymphoma and germ-cell tumor In the USA it is estimated that 34920 new cases of myeloma 81560 new cases of non-Hodgkin lymphoma and 8830 new cases of Hodgkin lymphoma will be diagnosed annually

Auto-HSCT is the first line therapy for fit patients with plasma cell myeloma and second line therapy for fit patients with relapsedrefractory lymphoma It significantly prolongs overall survival in patients with myeloma and provides chances of cure in patients with relapsedrefractory lymphoma The prerequisite condition to successfully perform an auto-HSCT is to mobilize and harvest an adequate amount of autologous hematopoietic stem cells Usually a number of 075-25 x 106kg CD34 cell is the minimal amount of hematopoietic stem cells required to safely perform an auto-HSCT Recent study revealed increased amount of CD34 autologous hematopoietic stem cell dose in auto-HSCT as a predictor of shortened engraftment time and better survival

Before PBSC peripheral blood stem cell harvest the hematopoietic stem cells need to be mobilized from bone marrow into the peripheral blood In patients with malignant diseases chemo-mobilization is the preferred mobilization method which consists of chemotherapy 1-2 weeks prior to the harvesting procedure Granulocyte colony-stimulating factor G-CSF is administered after the chemotherapy to facilitate PBSC mobilization Following chemotherapy and G-CSF PBSC will be mobilized into peripheral blood for harvest The concentration of PBSC will be monitored Once an adequate amount of PBSC is measured a PBSC harvest procedure will be initiated The PBSC harvest procedure usually starts 1-2 weeks following chemotherapy and takes 1-5 days until adequate amounts of PBSC are collected The more days a harvesting procedure takes the larger medical risks and costs it possesses

ESHAP is one of the most commonly used chemo-mobilization regimens in National Taiwan University Hospital The unpublished data from National Taiwan University Hospital revealed that it took at least 2 days to obtain adequate amount of PBSC for auto-HSCT in 4084 of patients

Under certain circumstances patients may never obtain adequate amounts of PBSC for auto-HSCT even after 5 days of PBSC harvest or salvage treatment with plerixafor a stem cell mobilizer agent Compared to patients who obtained an adequate amount PBSC in the 1st day of stem cell harvest these patients undertook more risks during harvest procedure and cost more medical expenditure In addition plerixafor is an expensive medication 9255 USDeach supply that is conditional reimbursed in Taiwan It is likely to be unaffordable for patients outside Taiwan or those without reimbursement Without adequate amounts of harvested stem cells the standard treatment of lymphoma auto-HSCT cant be performed and patients outcome will be severely compromised Theres an urgent need to increase the percentage of patients gathering an adequate amount of PBSC on the first harvest day

Eltrombopag is a thrombopoietin TPO receptor agonist that has been approved by the United States Food and Drug Administration for the treatment of immune thrombocytopenia 2007 and aplastic anemia 2014 It has been proven that TPO agonists can stimulate stem cell proliferation and maintenance One study showed administration of eltrombopag increased the stem cell amount harvested from patients with plasma cell myeloma Investigators hypothesized that addition of eltrombopag during ESHAP PBSC mobilization will increase the amount of harvested stem cells in patients with lymphoma

In addition a study in patients with aplastic anemia showed positive correlation of serum eltrombopag concentration with treatment efficacy A higher peak serum eltrombopag concentration were associated with higher response rate This raises the interest of measuring serum eltrombopag in this study The association of serum eltrombopag concentration and harvested PBSC amount will be explored as well

In conclusion this study aimed to explore the activity of eltrombopag in ESHAP PBSC mobilization Participants will receive eltrombopag following ESHAP chemo-mobilization The amount of PBSC and its association with peak serum eltrombopag will be measured

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None