Using eltrombopag to enhance stem cell harvest in lymphoma patients
Eltrombopag Plus G-CSF for Human CD34+ Cell Mobilization in Patients With Lymphoma Undergoing Autologous Stem Cell Harvest
This study is testing if adding eltrombopag to standard chemotherapy can help lymphoma patients collect more stem cells from their blood for treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | rituximab, brentuximab, chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05961410 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of eltrombopag in increasing the yield of peripheral blood stem cells during autologous hematopoietic stem cell mobilization in patients with lymphoma. Participants will receive eltrombopag alongside standard chemotherapy to mobilize stem cells from the bone marrow into the bloodstream. The study aims to compare the amount of harvested stem cells with historical data to determine if eltrombopag improves outcomes. Additionally, it will assess the pharmacokinetics and pharmacodynamics of eltrombopag in this context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Hodgkin or non-Hodgkin lymphoma who have achieved a complete, partial, or stable response after chemotherapy.
Not a fit: Patients with a history of severe reactions to eltrombopag or those with certain liver conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved stem cell harvests, enhancing treatment outcomes for lymphoma patients undergoing transplantation.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ta-Chuan Yu, MD — National Taiwan University Hospital
- Study coordinator: Ta-Chuan Yu, MD
- Email: youthyear@gmail.com
- Phone: +886932656912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.