A Study of Combined Deferasirox, Vitamin D and Azacytidine in High Risk MDS
Status:
Unknown status
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
Summary
Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine
in treatment of high risk MDS
Deferasirox Exjade:
The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is
scheduled during the phase I, with 5 additional patients per group.
The maximal tolerated dose of Deferasirox will be required for the phase II of the study.
The first dose will be assigned according to the ferritin level of the patient at time of
inclusion:
5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin
is ≥1000ng/ml) in Group 2
Group 1 : Ferritin 300 to 1000ng /ml:
- cohort 1 : 5 mg/kg/d
- cohort 2 : 10mg/kg/d
- cohort 3 : 15 mg/kg/d
Group 2 : Ferritin > 1000ng /ml:
- cohort 1 : 10 mg/kg/d
- cohort 2 : 15mg/kg/d
- cohort 3 : 20 mg/kg/d
5 patients will be treated by cohort. In absence of toxicity (extra-hematological
toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included
in the next cohort.
Deferasirox will be administrated once daily during all the study period. Uvedose will be
administrated once weekly during all the study period (100.000 UI P.O).
Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each
cycles(One cycle is 28 days)
During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine
Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity
or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to
evaluate the efficacy of the treatment.
No dose modification of deferasirox will be done after 3 cycles of treatment except in case
of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with
the same dose of Deferasirox until progression .
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Collaborator:
Novartis
Treatments:
Azacitidine Deferasirox Ergocalciferols Vitamin D Vitamins