Eltrombopag for Peripheral Blood Stem Cell Harvest
Eltrombopag Plus G-CSF for Human CD34+ Cell Mobilization in Patients With Lymphoma Undergoing Autologous Stem Cell Harvest
National Taiwan University Hospital
46 participants
Aug 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria13
- 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
Interventions
Patients will receive eltrombopag 75 mg/day from ESHAP D6 until end of stem cell harvest.
Locations(1)
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NCT05961410