Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents (LODEFI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03387475|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplasia||Drug: Deferasirox||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk (MDS) Myelodysplastic Syndrome Resistant or Relapsing After ESA Agents (LODEFI)|
|Actual Study Start Date :||February 20, 2018|
|Estimated Primary Completion Date :||February 19, 2022|
|Estimated Study Completion Date :||February 19, 2022|
efficacy of 3.5mg/kg/day
Other Name: exjade
- Percentage of patients without transfusion-dependence at 12 months. [ Time Frame: 12 months ]Percentage of patients without transfusion-dependence at 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387475
|Contact: Sophie Park||0476762777||Spark@chu-grenoble.fr|
|Contact: Valérie Rolland||0476765096||VRollandfirstname.lastname@example.org|
|CHU de GRENOBLE ALPES||Recruiting|
|Grenoble, France, 38043|
|Contact: Sophie PARK 04 76 76 27 77 SPark@chu-grenoble.fr|
|Principal Investigator:||Sophie Park||University Hospital, Grenoble|