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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Eltrombopag olamine

Patients will receive eltrombopag 75 mg/day from ESHAP D6 until end of stem cell harvest.

Locations (1)

National Taiwan University Hospital
Taipei, Taiwan