Overview

VALIDATION OF A PREDICTIVE MODEL OF RESPONSE TO ROMIPLOSTIM IN PATIENTS WITH IPSS LOW OR INTERMEDIATE-1 RISK MDS AND THROMBOCYTOPENIA

Status:
Completed

Trial end date:
2021-05-20

Target enrollment:

Participant gender:

Summary

There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.

Phase:

Phase 2

Details

Lead Sponsor:

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH