NCT03387475CompletedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
Patients with low-risk MDS verifying the eligibility criteria may be included in the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 22 Dec 2017
- Start date
- 20 Feb 2018
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT03387475
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 39
- From 20 Feb 2018 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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.
Lab values
- Creatinine clearance according to MDRD ≤60 ml / min
Other
- Transfusion dependent patient (≥) 2 red blood cells (RBP) per 2-month period evaluated over 4 months between M-4 and M0
- Ferritin \<200 ng / ml
- Iron overload: ferritin\> 1000 ng / ml
- 5q- deletion to karyotype
- Patient eligible for allograft
- Patient participating in another interventional clinical study or exclusion period from another study
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de GRENOBLE ALPES Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.