Hematologic Malignancy Clinical Trial
Official title:
A Phase 1/2 Study of MPH966, an Oral Neutrophil Elastase Inhibitor, for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is evaluate the safety and tolerability of MPH966, a neutrophil elastase inhibitor, and its ability to prevent graft-versus-host disease after hematopoietic stem cell transplant.
Phase 1 is a 3+3 dose escalation study to determine the safety and recommended phase 2 dose
(RP2D) of MPH966 in patients undergoing allogeneic hematopoietic stem cell transplantation
(HCT). We will evaluate up to 4 doses: 60 mg po bid, 120 mg po bid, 180 mg po bid, and 240 mg
po bid. Safety, tolerability, and efficacy will be assessed in real time and pharmacokinetics
and pharmacodynamics after each dose cohort before escalating to the next cohort.
Phase 2 is a randomized, double-blind, placebo-controlled study to determine the clinical
efficacy of MPH966 vs. placebo in preventing acute graft-versus-host disease (GVHD) after
HCT, using the RP2D as determined by the phase 1 trial.
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