NCT05961410 Eltrombopag for Peripheral Blood Stem Cell Harvest
| NCT ID | NCT05961410 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Taiwan University Hospital |
| Condition | Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2023-08-15 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2023-08-15 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ta-Chuan Yu, MD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT05961410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05961410 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05961410 currently recruiting?
Yes, NCT05961410 is actively recruiting participants. Contact the research team at youthyear@gmail.com for enrollment information.
Where is the NCT05961410 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT05961410 clinical trial?
NCT05961410 is sponsored by National Taiwan University Hospital. The principal investigator is Ta-Chuan Yu, MD at National Taiwan University Hospital. The trial plans to enroll 46 participants.