NCT02663752

A Phase II Pilot Study to Assess the Presence of Molecular Factors Predictive for Hematologic Response in Myelodysplastic Syndrome Patients Receiving Deferasirox Therapy.

A Phase II Pilot Study to Assess the Presence of Molecular Factors Predictive for Hematologic Response in Myelodysplastic Syndrome Patients Receiving Deferasirox Therapy in Hematological Centers in Belgium Using Gene Expressing Profiling From Baseline Bone Marrow.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Several previous studies (clinical and non-clinical) hypothesize that treatment with deferasirox causes a hematological improvement in transfused patients with low and intermediate-1 risk myelodysplastic syndrome. The purpose of this study was to assess the presence of genetic biomarkers predictive for hematologic response by the use of gene expression profiling of bone marrow aspirates obtained from MDS patients with or without hematological response.

Detailed description

This trial was terminated due to low enrollment.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
PROCEDURE	Bone marrow aspirate	Patients experiencing a hematological response and patients not experiencing a hematological response while on deferasirox treatment received a new bone marrow aspirate in order to investigate the presence of differential gene expression between those two groups
DRUG	Deferasirox	Patients are already on commercial deferasirox before entering the study.

Timeline

• Start date: 2016-05-30
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-01-26
• Last updated: 2018-08-23
• Results posted: 2018-07-05

Locations

1 site across 1 country: Belgium