Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function (NCT03718533) | Clinical Trial Compass
TerminatedPhase 2
Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function
Stopped: In the context of COVID-19 pandemic, the benefit / risk ratio of the participation of a patient with pancytopenia could be compromised. The decision of this premature termination was not the consequence of any safety reason inherent to the drug.
Spain10 participantsStarted 2018-12-17
Plain-language summary
The purpose of this study was to evaluate the efficacy of eltrombopag for poor graft function (PGF) on overall hematologic response (partial and complete), as determined by platelet, hemoglobin and neutrophil counts by 16 weeks after the initiation of eltrombopag in patients with poor graft function after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must provide written, signed and dated informed consent form before any study assessment is performed
✓. Male of female patients ≥ 18 years of age
✓. Patients diagnosed with primary or secondary poor graft function (PGF) defined as two or more cytopenias after day +30 post-transplant (re-tested in a peripheral blood analysis at screening):
✓. Platelet count \<20,000/ µL (mandatory)
✓. Absolute neutrophil count (ANC) \<1,000/µL
✓. Hemoglobin \<100 g/L
✓. Presence of donor chimerism \>90% in screening visit
✓. Karnofsky status ≥90% (Karnofsky assessment must be performed within 7 days prior to Day 1)
Exclusion criteria
✕. Pregnant or nursing (lactating women).
What they're measuring
1
Hematologic Response Rate by 16 Weeks After the Initiation of Eltrombopag