NCT03387475

Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents

Phase II Trial Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk (MDS) Myelodysplastic Syndrome Resistant or Relapsing After ESA Agents (LODEFI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Patients with low-risk MDS verifying the eligibility criteria may be included in the study.

Detailed description

Patients will receive the number of DFX tablets (Exjade, cp film-coated, 90mg or 360mg), in relation to their body weight to be closer to 3.5mg / kg / d for 12 months. At one month and six months of treatment, the residual plasma levels of DFX will be measured in patients (sent to the Bordeaux laboratory of Biochemistry, Pr Molimard) to allow the dosage to be adjusted (plasma objective of 3 μM). At inclusion (J1) and at 6 months of treatment, a dosage of NTBI and hepcidine will be performed. If patients become transfusion-dependent (≥) 2 packed red cells (RBP) per 2-month period evaluated over 6 months, they will stop low-dose DFX and go out of protocol to receive DFX at 20mg / kg (according to EMEA authorization) for iron chelation.

Conditions

• Myelodysplasia

Interventions

Type	Name	Description
DRUG	Deferasirox	iron chelation

Timeline

• Start date: 2018-02-20
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2018-01-02
• Last updated: 2024-12-16

Locations

1 site across 1 country: France