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Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes

NCT00411905

CompletedPhase 1, Phase 2

Sponsor: Groupe Francophone des Myelodysplasies

Conditions: Myelodysplastic Syndromes

Interventions: Bortezomib

Countries: France

We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* MDS with IPSS scores Int-2 or High
* Life expectancy greater than 6 months
* No other available treatment options

Exclusion Criteria:

* MDS with IPSS scores Low or Int-1
* \> 30% bone marrow blasts
* clinical neuropathy of greater than grade 2
* ECOG Score 3 or 4
* Creatinine clearance of \< 30 ml/min
* LMMC
* Pregnant patients or lactating mothers
* Patients having received intensive chemotherapy in the 3 months prior to inclusion
* Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders

Locations (15)

Angers, France
Bobigny, France
Bordeaux, France
Caen, France
Dijon, France
Grenoble, France
Limoges, France
Marseille, France
Nice, France
Paris, France
Perpignan, France
Rouen, France
Strasbourg, France
Toulouse, France
Vandœuvre-lès-Nancy, France