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Eltrombopag for Poor Graft Function after Allo-HSCT

NCT03718533Phase 2

Key facts

Status: Terminated
Start: Dec 2018
Primary completion: Nov 2020
Countries: 1
Sponsor: Novartis
Modality: Small Molecules

Drugs: eltrombopag
Conditions: poor graft function (PGF)

Overview

Phase 2, open-label, single-arm trial of eltrombopag in poor graft function (PGF), sponsored by Novartis. Primary endpoint: Hematologic Response Rate by 16 Weeks After the Initiation of Eltrombopag. Started Dec 2018; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Eltrombopag
Patients received eltrombopag orally once daily up to 36 weeks.

Who it enrols

Adult patients with primary or secondary poor graft function (PGF) defined as >=2 cytopenias after day +30 post-transplant with >90% donor chimerism. Excludes patients with active GVHD, active malignancy, liver cirrhosis, or specific cardiac/viral conditions.

Endpoints

Primary

Hematologic Response Rate by 16 Weeks After the Initiation of Eltrombopag16 weeks

Secondary

Percentage of Participants Who Had a Response in the Neutrophil Lineage36 weeks
Percentage of Participants Who Had a Response in the Platelet Lineage36 weeks
Percentage of Participants Who Had a Response in the Hemoglobin Lineage36 weeks
Hematologic Response Rate at Week 24 and 3636 weeks
Percentage of Participants Who Were Previously Platelet Transfusion-dependent and Did no Longer Require Platelet Transfusions After the Initiation of Eltrombopag36 weeks
Percentage of Participants Who Were Previously Red Blood Cells Transfusion-dependent and Did no Longer Require Red Blood Cells Transfusions36 weeks
Duration of Transfusion Independence36 weeks
Percentage of Participants Who Discontinued or Reduced the Use of Concomitant Erythropoietin (EPO) Therapy36 weeks

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