MedTrace Logo

Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia

NCT02335268 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-08-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

N-Plate / romiplostim

medical intervention in 3 patient groups (MDS patients with IPSS Low/Int-1) that are stratified according to their baseline TPO-Level and previous transfusions

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

    lead OTHER

Principal Investigators

  • Uwe Platzbecker, Prof. Dr. · University of Dresden

  • Lionel Ades, Prof. Dr. · Groupe Francophone des Myelodysplasies

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-21
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02335268 on ClinicalTrials.gov