Eltrombopag for Peripheral Blood Stem Cell Harvest (EPBSCH)

December 27, 2023 updated by: National Taiwan University Hospital

Eltrombopag Plus G-CSF for Human CD34+ Cell Mobilization in Patients With Lymphoma Undergoing Autologous Stem Cell Harvest

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 34,920 new cases of myeloma, 81,560 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 relapsed/refractory lymphoma. It significantly prolongs overall survival in patients with myeloma and provides chances of cure in patients with relapsed/refractory 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 0.75-2.5 x 10^6/kg 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 40.84% 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 ($9,255 USD/each 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) can't be performed and patient's outcome will be severely compromised. There's 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 Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Ta-Chuan Yu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: ≥ 18 years
  • Diagnosis: Hodgkin lymphoma or non-Hodgkin lymphoma
  • Disease status: complete response, partial response, or stable disease after at least 2 cycles of treatment (see appendix 2 for definition)
  • Planned to receive ESHAP (etoposide, steroid, high-dose cytarabine, cisplatin) chemotherapy with/without monoclonal antibody (ex: rituximab, brentuximab) as chemo-mobilization for stem cell harvest
  • East-Asian heritage

Exclusion Criteria:

  • History of vascular thromboembolic event
  • Steady state platelet count > 1000k/μL
  • Documented cytogenetic abnormalities in marrow blood
  • Current administration of eltrombopag
  • History of grade III-IV hepatotoxicity to eltrombopag 75/mg/day
  • Life-threatening allergic reactions to eltrombopag
  • Baseline serum aspartate aminotransferase (AST), alanine aminotransferase(ALT) or total bilirubin > 3 fold of upper limit of normal
  • Pregnancy or breast-feeding
  • Patients with hepatitis C receiving interferon and ribavirin treatment
  • Concurrent active cancer other than lymphoma
  • Eastern Cooperative Oncology Group (ECOG) 3-4 (see appendix 4 for definition)
  • Moribund status such as concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious disease that death within 30 days is likely.
  • Inability to understand the investigational nature of the study or to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eltrombopag
ESHAP + Eltrombopag as peripheral blood stem cell mobilization
Drug: Eltrombopag olamine
Patients will receive eltrombopag 75 mg/day from ESHAP D6 until end of stem cell harvest.
Other Names:
  • Revolade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of harvested CD34+ cells in first stem cell harvest day
Time Frame: 1 day (first stem cell harvest day)
1 day (first stem cell harvest day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 8 months
8 months
Engraftment time (days) of granulocytes
Time Frame: Whole hematopoietic stem cell transplantation process, an average of 4 weeks
The time needed to achieve absolute neutrophil count > 500 x 10^6/L after stem cell infusion in study participants
Whole hematopoietic stem cell transplantation process, an average of 4 weeks
Engraftment time (days) of platelets
Time Frame: Whole hematopoietic stem cell transplantation process, an average of 4 weeks
The time needed to achieve platelet > 20,000/L without transfusion after stem cell infusion in study participants
Whole hematopoietic stem cell transplantation process, an average of 4 weeks
Peak serum eltrombopag concentration
Time Frame: 3 weeks
Peak serum eltrombopag concentration
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Novartis

Investigators

  • Principal Investigator: Ta-Chuan Yu, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 9, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301091MIFC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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