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Eltrombopag for Peripheral Blood Stem Cell Harvest

RECRUITINGPhase 2Sponsored by National Taiwan University Hospital
Actively Recruiting
PhasePhase 2
SponsorNational Taiwan University Hospital
Started2023-08-15
Est. completion2025-03-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05961410

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerLymphomaPeripheral Blood Stem Cell Transplantation

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