Eltrombopag for Peripheral Blood Stem Cell Harvest

NCT05961410 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202301091MIFC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.
• 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

Lymphoma; Peripheral Blood Stem Cell Transplantation

Keywords

Lymphoma; Peripheral Blood Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Number of harvested CD34+ cells in first stem cell harvest day

  1 day (first stem cell harvest day)

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  8 months

• Engraftment time (days) of granulocytes

  Whole hematopoietic stem cell transplantation process, an average of 4 weeks

• Engraftment time (days) of platelets

  Whole hematopoietic stem cell transplantation process, an average of 4 weeks

• Peak serum eltrombopag concentration

  3 weeks

Study Arms (1)

Eltrombopag

EXPERIMENTAL

ESHAP + Eltrombopag as peripheral blood stem cell mobilization

Drug: Eltrombopag olamine

Interventions

Eltrombopag olamine DRUG

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

Also known as: Revolade

Eltrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Novartis: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 9763111 BACKGROUND

• Zuo 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 BACKGROUND

• Zhu 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 BACKGROUND

• Scheinberg P. Activity of eltrombopag in severe aplastic anemia. Blood Adv. 2018 Nov 13;2(21):3054-3062. doi: 10.1182/bloodadvances.2018020248.

  PMID: 30425070 BACKGROUND

MeSH Terms

Conditions

Lymphoma

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ta-Chuan Yu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ta-Chuan Yu, MD

CONTACT

+886932656912; youthyear@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 27, 2023
• Study Start: August 15, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-09

Locations

TW (1)