Prospective validation of a predictive model of response to romiplostim in patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia - the EUROPE-trial - Europe

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia
Sponsor: GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Enrollment: 90
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

January 15, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects must meet the following inclusion criteria tobe eligible for the study,
•1\.Must understand and voluntarily sign an informed consent form
•2\.Age \> 18 years at the time of signing the informed consent form
•3\.Must be able to adhere to the study visit schedule and other protocol requirements
•4\.Diagnosis of MDS using the WHO classification for myeloid neoplasms (Vardiman et al, 2002\) as assessed during the screening period
•5\.Per MDS IPSS, low or intermediate\-1 risk MDS as assessed during the screening period
•6\.The mean of the 2 platelet counts taken within 4 weeks prior to stratification must be:
•\= 30 x 109/L (with no individual count \> 30 x 109/L during the screening period), with or without a history of bleeding associated with the diagnosis of MDS, OR
•\< 50 x 109/L (with no individual count \>60 x 109/L during the screening period), with a history of bleeding associated with the diagnosis of MDS
•(A standard of care platelet count taken prior to Informed consent may be used as 1 of the 2 counts taken within 4 weeks prior to randomization)

•1\.Pregnant or lactating females
•2\.IPSS intermediate\-2 or high\-risk
•3\.\= 5% blasts in the bone marrow as determined by central morphology during screening
•4\.Previous treatment with any thrombopoietic growth factor
•5\.Prior history of hematopoietic stem cell transplantation
•6\.Active or uncontrolled disease including infections or cancer
•7\.Unstable angina, congestive heart failure (NYHA \> class II), uncontrolled hypertension
•8\.History of arterial thrombosis (eg, stroke or transient ischemic attack) within the past year
•9\.History of venous thrombosis that currently requires anti\-coagulation therapy
•10\.Received IL\-11 within 4 weeks of the first dose of investigational product