Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-03-08 @ 1:07 AM
Study NCT ID:
NCT01718366
Status:
UNKNOWN
Last Update Posted:
2018-01-10
First Post:
2012-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Combined Deferasirox, Vitamin D and Azacytidine in High Risk MDS
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Study Overview
Official Title:
Phase I-II Study of Association of Deferasirox, Vitamin D and Azacytidine as Treatment of High Risk MDS (IPSS Int-2 and High)
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GFM-EXVD-AZA
Brief 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Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to evaluate the efficacy of the treatment.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 .
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 .
Detailed Description:
Deferasirox will be administrated once daily in the morning on an empty stomach, 30 minutes before meal.
Deferasirox will be stopped if the ferritin level is under 100 ng/ml,and could be restarted is the ferritin level increase to 200 ng/ml
Uvedose dose could be adjusted according to the phosphocalcic metabolism parameters and the plasma Vitamin D3 level.
Deferasirox will be stopped if the ferritin level is under 100 ng/ml,and could be restarted is the ferritin level increase to 200 ng/ml
Uvedose dose could be adjusted according to the phosphocalcic metabolism parameters and the plasma Vitamin D3 level.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: