Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Peripheral Blood Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eltrombopag olamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eltrombopag
- description
- ESHAP + Eltrombopag as peripheral blood stem cell mobilization
- interventionNames
- Drug: Eltrombopag olamine
Primary outcomes (1)
- measure
- Number of harvested CD34+ cells in first stem cell harvest day
- timeFrame
- 1 day (first stem cell harvest day)
Secondary outcomes (4)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- timeFrame
- 8 months
- measure
- Engraftment time (days) of granulocytes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDShpall EJ, Champlin R, Glaspy JA. Effect of CD34+ peripheral blood progenitor cell dose on hematopoietic recovery. Biol Blood Marrow Transplant. 1998;4(2):84-92. doi: 10.1053/bbmt.1998.v4.pm9763111. PMID 9763111
- BACKGROUNDZuo W, Zhang B, Ruan J, Chen M, Han B. Correlation of the Plasma Concentration of Eltrombopag With Efficacy in the Treatment of Refractory Aplastic Anemia: A Single-Centre Study in China. Front Pharmacol. 2020 Nov 16;11:582625. doi: 10.3389/fphar.2020.582625. eCollection 2020. PMID 33364958
- BACKGROUNDZhu J, Hao SG, Hu J, Zhuang JL, Wang C, Bai HT. rhTPO combined with chemotherapy and G-CSF for autologous peripheral blood stem cells in patients with refractory/relapsed non-Hodgkin's lymphoma. Cancer Manag Res. 2019 Sep 13;11:8371-8377. doi: 10.2147/CMAR.S219242. eCollection 2019. PMID 31571993
- BACKGROUNDScheinberg P. Activity of eltrombopag in severe aplastic anemia. Blood Adv. 2018 Nov 13;2(21):3054-3062. doi: 10.1182/bloodadvances.2018020248. PMID 30425070