PrE0901: Phase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults with Acute Myeloid Leukemia (AML) in Complete Remission

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PrE0901: Phase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults with Acute Myeloid Leukemia (AML) in Complete Remission

2.1 Phase I Primary Objectives
2.1.1 To determine the safety, tolerability and optimal dose of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy.
2.1.2 To describe the kinetics of platelet count recovery in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy who will be receiving eltrombopag.
2.2 Phase I and Phase II Secondary Objective
2.2.1 To determine the plasma concentrations of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy (selected dosing regimen only).
2.3 Phase II Primary Objective
2.3.1 To determine if platelet recovery following consolidation chemotherapy is accelerated with eltrombopag.
2.4 Phase II Secondary Objectives
2.4.1 To determine the impact of eltrombopag on platelet transfusion requirements in the setting of consolidation chemotherapy.
2.4.2 To determine the impact of eltrombopag on red blood cell transfusion requirements.
2.4.3 To determine the impact of eltrombopag on occurrence of bleeding events.
2.4.4 To determine the impact of eltrombopag on time to platelet recovery following consolidation chemotherapy.
2.4.5 To determine the impact of eltrombopag on the depth of platelet nadir following a cycle of consolidation chemotherapy.
2.4.6 To determine the duration of platelet nadir in the setting of eltrombopag exposure.
2.4.7 To determine the safety and tolerability of eltrombopag when given at the optimal dose in the setting of consolidation chemotherapy.
2.5 Exploratory Objective
2.5.1 To determine if eltrombopag has an effect on TPO and/or EPO in this setting.

Protocol Number021304
Principal InvestigatorDale Schaar
PhasePhase I/II
ScopeNational
Applicable Disease SitesAny Site
Therapies InvolvedChemotherapy (NOS)
Drugs InvolvedPLACEBO
Eltrombopag
CYTARABINE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.