LymphomaPhase 2EPBSCHNCT05961410
Eltrombopag for Peripheral Blood Stem Cell Harvest
A Phase 2 study testing Eltrombopag olamine in people with Lymphoma and Peripheral Blood Stem Cell Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Peripheral Blood Stem Cell Transplantation
- What is being tested?
- Eltrombopag olamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Aug 2023to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ta-Chuan Yu, MD, +886932656912, youthyear@gmail.com
Ta-Chuan Yu, MD
About this study
Official title: Eltrombopag Plus G-CSF for Human CD34+ Cell Mobilization in Patients With Lymphoma Undergoing Autologous Stem Cell Harvest
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.
Read the detailed description
Autologous hematopoietic stem cell transplantation (auto-HSCT) is the standard treatment for many malignant diseases, including plasma cell myeloma, lymphoma and germ-cell tumor. In the USA, it is estimated that 34,920 new cases of myeloma, 81,560 new cases of non-Hodgkin lymphoma, and 8830 new cases of Hodgkin lymphoma will be diagnosed annually.
Auto-HSCT is the first line therapy for fit patients with plasma cell myeloma and second line therapy for fit patients with relapsed/refractory lymphoma. It significantly prolongs overall survival in patients with myeloma and provides chances of cure in patients with relapsed/refractory lymphoma. The prerequisite condition to successfully perform an auto-HSCT is to mobilize and harvest an adequate amount of autologous hematopoietic stem cells. Usually, a number of 0.75-2.5 x 10^6/kg CD34+ cell is the minimal amount of hematopoietic stem cells required to safely perform an auto-HSCT. Recent study revealed increased amount of CD34+ autologous hematopoietic stem cell dose in auto-HSCT as a predictor of shortened engraftment time and better survival.
Before PBSC (peripheral blood stem cell) harvest, the hematopoietic stem cells need to be mobilized from bone marrow into the peripheral blood. In patients with malignant diseases, chemo-mobilization is the preferred mobilization method, which consists of chemotherapy 1-2 weeks prior to the harvesting procedure. Granulocyte colony-stimulating factor (G-CSF) is administered after the chemotherapy to facilitate PBSC mobilization. Following chemotherapy and G-CSF, PBSC will be mobilized into peripheral blood for harvest. The concentration of PBSC will be monitored. Once an adequate amount of PBSC is measured, a PBSC harvest procedure will be initiated. The PBSC harvest procedure usually starts 1-2 weeks following chemotherapy, and takes 1-5 days until adequate amounts of PBSC are collected. The more days a harvesting procedure takes, the larger medical risks and costs it possesses.
ESHAP is one of the most commonly used chemo-mobilization regimens in National Taiwan University Hospital. The unpublished data from National Taiwan University Hospital revealed that, it took at least 2 days to obtain adequate amount of PBSC for auto-HSCT in 40.84% of patients.
Under certain circumstances, patients may never obtain adequate amounts of PBSC for auto-HSCT even after 5 days of PBSC harvest or salvage treatment with plerixafor, a stem cell mobilizer agent. Compared to patients who obtained an adequate amount PBSC in the 1st day of stem cell harvest, these patients undertook more risks during harvest procedure and cost more medical expenditure. In addition, plerixafor is an expensive medication ($9,255 USD/each supply) that is conditional reimbursed in Taiwan. It is likely to be unaffordable for patients outside Taiwan or those without reimbursement. Without adequate amounts of harvested stem cells, the standard treatment of lymphoma (auto-HSCT) can't be performed and patient's outcome will be severely compromised. There's an urgent need to increase the percentage of patients gathering an adequate amount of PBSC on the first harvest day.
Eltrombopag is a thrombopoietin (TPO) receptor agonist that has been approved by the United States Food and Drug Administration for the treatment of immune thrombocytopenia (2007) and aplastic anemia (2014). It has been proven that TPO agonists can stimulate stem cell proliferation and maintenance. One study showed administration of eltrombopag increased the stem cell amount harvested from patients with plasma cell myeloma. Investigators hypothesized that addition of eltrombopag during ESHAP PBSC mobilization will increase the amount of harvested stem cells in patients with lymphoma.
In addition, a study in patients with aplastic anemia showed positive correlation of serum eltrombopag concentration with treatment efficacy. A higher peak serum eltrombopag concentration were associated with higher response rate. This raises the interest of measuring serum eltrombopag in this study. The association of serum eltrombopag concentration and harvested PBSC amount will be explored as well.
In conclusion, this study aimed to explore the activity of eltrombopag in ESHAP PBSC mobilization. Participants will receive eltrombopag following ESHAP chemo-mobilization. The amount of PBSC, and its association with peak serum eltrombopag will be measured.
- Being tested
- Eltrombopag olamine
- Keywords
- Lymphoma, Peripheral Blood Stem Cell Transplantation
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eltrombopag olamineDrug
Also called Revolade
Patients will receive eltrombopag 75 mg/day from ESHAP D6 until end of stem cell harvest.
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | ESHAP + Eltrombopag as peripheral blood stem cell mobilization Receives: Drug: Eltrombopag olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of harvested CD34+ cells in first stem cell harvest day
Measured: 1 day (first stem cell harvest day)
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 8 months
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
Measured: Whole hematopoietic stem cell transplantation process, an average of 4 weeks
Engraftment time (days) of platelets
The time needed to achieve platelet > 20,000/L without transfusion after stem cell infusion in study participants
Measured: Whole hematopoietic stem cell transplantation process, an average of 4 weeks
Peak serum eltrombopag concentration
Peak serum eltrombopag concentration
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Aug 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Ta-Chuan Yu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961410
- Sponsor's protocol ID
- 202301091MIFC
- Acronym
- EPBSCH
- Status last verified
- Sep 2024
- First submitted
- 9 Jul 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shpall 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.
PubMed 9763111Zuo 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.
PubMed 33364958Zhu 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.
PubMed 31571993Scheinberg P. Activity of eltrombopag in severe aplastic anemia. Blood Adv. 2018 Nov 13;2(21):3054-3062. doi: 10.1182/bloodadvances.2018020248.
PubMed 30425070
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eltrombopag Plus G-CSF for Human CD34+ Cell Mobilization in Patients With Lymphoma Undergoing Autologous Stem Cell Harvest
- ClinicalTrials.gov ID
- NCT05961410
- Acronym / sponsor ID
- EPBSCH / 202301091MIFC
- Keywords
- Lymphoma, Peripheral Blood Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autologous hematopoietic stem cell transplantation (auto-HSCT) is the standard treatment for many malignant diseases, including plasma cell myeloma, lymphoma and germ-cell tumor. In the USA, it is estimated that 34,920 new cases of myeloma, 81,560 new cases of non-Hodgkin lymphoma, and 8830 new cases of Hodgkin lymphoma will be diagnosed annually.
Auto-HSCT is the first line therapy for fit patients with plasma cell myeloma and second line therapy for fit patients with relapsed/refractory lymphoma. It significantly prolongs overall survival in patients with myeloma and provides chances of cure in patients with relapsed/refractory lymphoma. The prerequisite condition to successfully perform an auto-HSCT is to mobilize and harvest an adequate amount of autologous hematopoietic stem cells. Usually, a number of 0.75-2.5 x 10^6/kg CD34+ cell is the minimal amount of hematopoietic stem cells required to safely perform an auto-HSCT. Recent study revealed increased amount of CD34+ autologous hematopoietic stem cell dose in auto-HSCT as a predictor of shortened engraftment time and better survival.
Before PBSC (peripheral blood stem cell) harvest, the hematopoietic stem cells need to be mobilized from bone marrow into the peripheral blood. In patients with malignant diseases, chemo-mobilization is the preferred mobilization method, which consists of chemotherapy 1-2 weeks prior to the harvesting procedure. Granulocyte colony-stimulating factor (G-CSF) is administered after the chemotherapy to facilitate PBSC mobilization. Following chemotherapy and G-CSF, PBSC will be mobilized into peripheral blood for harvest. The concentration of PBSC will be monitored. Once an adequate amount of PBSC is measured, a PBSC harvest procedure will be initiated. The PBSC harvest procedure usually starts 1-2 weeks following chemotherapy, and takes 1-5 days until adequate amounts of PBSC are collected. The more days a harvesting procedure takes, the larger medical risks and costs it possesses.
ESHAP is one of the most commonly used chemo-mobilization regimens in National Taiwan University Hospital. The unpublished data from National Taiwan University Hospital revealed that, it took at least 2 days to obtain adequate amount of PBSC for auto-HSCT in 40.84% of patients.
Under certain circumstances, patients may never obtain adequate amounts of PBSC for auto-HSCT even after 5 days of PBSC harvest or salvage treatment with plerixafor, a stem cell mobilizer agent. Compared to patients who obtained an adequate amount PBSC in the 1st day of stem cell harvest, these patients undertook more risks during harvest procedure and cost more medical expenditure. In addition, plerixafor is an expensive medication ($9,255 USD/each supply) that is conditional reimbursed in Taiwan. It is likely to be unaffordable for patients outside Taiwan or those without reimbursement. Without adequate amounts of harvested stem cells, the standard treatment of lymphoma (auto-HSCT) can't be performed and patient's outcome will be severely compromised. There's an urgent need to increase the percentage of patients gathering an adequate amount of PBSC on the first harvest day.
Eltrombopag is a thrombopoietin (TPO) receptor agonist that has been approved by the United States Food and Drug Administration for the treatment of immune thrombocytopenia (2007) and aplastic anemia (2014). It has been proven that TPO agonists can stimulate stem cell proliferation and maintenance. One study showed administration of eltrombopag increased the stem cell amount harvested from patients with plasma cell myeloma. Investigators hypothesized that addition of eltrombopag during ESHAP PBSC mobilization will increase the amount of harvested stem cells in patients with lymphoma.
In addition, a study in patients with aplastic anemia showed positive correlation of serum eltrombopag concentration with treatment efficacy. A higher peak serum eltrombopag concentration were associated with higher response rate. This raises the interest of measuring serum eltrombopag in this study. The association of serum eltrombopag concentration and harvested PBSC amount will be explored as well.
In conclusion, this study aimed to explore the activity of eltrombopag in ESHAP PBSC mobilization. Participants will receive eltrombopag following ESHAP chemo-mobilization. The amount of PBSC, and its association with peak serum eltrombopag will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag | Experimental | Drug: Eltrombopag olamineESHAP + Eltrombopag as peripheral blood stem cell mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eltrombopag olamineAlso: RevoladePatients will receive eltrombopag 75 mg/day from ESHAP D6 until end of stem cell harvest. | Drug | Eltrombopag |
Primary outcome
Number of harvested CD34+ cells in first stem cell harvest day
Time frame: 1 day (first stem cell harvest day)
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 8 months
Engraftment time (days) of granulocytes
Time frame: Whole hematopoietic stem cell transplantation process, an average of 4 weeks
Engraftment time (days) of platelets
Time frame: Whole hematopoietic stem cell transplantation process, an average of 4 weeks
Peak serum eltrombopag concentration
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 9763111Shpall 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.
- Background: PubMed 33364958Zuo 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.
- Background: PubMed 31571993Zhu 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.
- Background: PubMed 30425070Scheinberg P. Activity of eltrombopag in severe aplastic anemia. Blood Adv. 2018 Nov 13;2(21):3054-3062. doi: 10.1182/bloodadvances.2018020248.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ta-Chuan Yu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag olamine in people with Lymphoma and Peripheral Blood Stem Cell Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ta-Chuan Yu, MD (+886932656912, youthyear@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of harvested CD34+ cells in first stem cell harvest day (time frame: 1 day (first stem cell harvest day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961410, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.