Status:
COMPLETED
Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk MDS Resistant or Relapsing After ESA Agents
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Novartis
Conditions:
Myelodysplasia
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Patients with MDS according to WHO 2008 criteria (refractory anemia with multilineage dysplasia, RA (refractory anemia), refractory anemia with ringed sideroblasts (RARS) including CMML-1 (chronic myelomonocytic leukemia) type 1 with \<10% blasts)
- low risk (IPSS-R very low, low and intermediate)
- in primary or secondary failure after erythropoiesis stimulating agents (ESAs), (either epoetins (≥60,000 units / week), or darbepoetin (≥250 μg / week), administered for at least 12 weeks, as defined by the IWG criteria 2006 (no erythroid response at 12 weeks, or more than 15g / l decrease in Hb after response to ESAs) PS: Patients with low transfusion of less than (\<) 4RBP assessed over 4 months (RBP administered for patients with Hb ≤ 9g / dl) will be accepted)
- age ≥ 18 years
- ECOG ≤2
- informed consent dated and signed
- affiliated to a social security scheme
- Women and men of childbearing potential must have effective contraception throughout the duration of the study and up to 4 days after the last administration of deferasirox
Exclusion
- Transfusion dependent patient (≥) 2 red blood cells (RBP) per 2-month period evaluated over 4 months between M-4 and M0
- Patients with high-risk MDS (based on IPSS-R) and patients with other hematologic and non-haematological malignancies who should not benefit from chelation therapy due to rapid progression of their disease
- Ferritin \<200 ng / ml
- Iron overload: ferritin\> 1000 ng / ml
- Creatinine clearance according to MDRD ≤60 ml / min
- 5q- deletion to karyotype
- Patient eligible for allograft
- Patient participating in another interventional clinical study or exclusion period from another study
- History of cancer treated or untreated for less than 5 years, whether or not there are signs of relapse or metastases, with the exception of basocellular cancers.
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, can not not be included in clinical trials.
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03387475
Start Date
February 20 2018
End Date
October 1 2024
Last Update
December 16 2024
Active Locations (1)
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1
CHU de GRENOBLE ALPES
Grenoble, France, 38043