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A Study of Combined Deferasirox, Vitamin D and Azacytidine in High Risk MDS

NCT01718366 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-01-10

No results posted yet for this study

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Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to evaluate the efficacy of the treatment.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 .

Conditions

Interventions

DRUG

Deferasirox, Vitamin D and Azacitidine

association of Deferasirox (group 1: 5-10-15/mg/kg/day according to dose level group), Vitamine D (100000U/week) and Azacitidine (75 mg/kg/day day1-day7)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Olivier Hermine, MD · Necker Hospital (Paris)

  • Pierre Fenaux, MD · Saint Louis Hospital (Paris)

  • Felipe Suarez, MD · Necker Hospital (Paris)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Belgium
  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718366 on ClinicalTrials.gov