Eltrombopag for Peripheral Blood Stem Cell Harvest
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of vascular thromboembolic event
Steady state platelet count > 1000k/μL
Documented cytogenetic abnormalities in marrow blood
Current administration of eltrombopag
Trial design
Design model
Single group
Treatments tested in this trial
Eltrombopag olamine
DrugPatients will receive eltrombopag 75 mg/day from ESHAP D6 until end of stem cell harvest.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: EltrombopagExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of harvested CD34+ cells in first stem cell harvest day
Time frame
1 day (first stem cell harvest day)Secondary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
8 months2
Engraftment time (days) of granulocytes
The time needed to achieve absolute neutrophil count \> 500 x 10\^6/L after stem cell infusion in study participants
Time frame
Whole hematopoietic stem cell transplantation process, an average of 4 weeks3
Engraftment time (days) of platelets
The time needed to achieve platelet \> 20,000/L without transfusion after stem cell infusion in study participants
Time frame
Whole hematopoietic stem cell transplantation process, an average of 4 weeks4
Peak serum eltrombopag concentration
Peak serum eltrombopag concentration
Time frame
3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Novartis
Collaborator
Source ClinicalTrials.gov