Clinical trial NCT00411905: Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
Official title: Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic syndromes
IPSS Int-2 and High risk
Bortezomib
Low dose Cytarabine
Bone Marrow diseases
Lead sponsor: Groupe Francophone des Myelodysplasies
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2006-12-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Essai ouvert multicentrique de phase I-II
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting

Cycle 1 :

* Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
* Bortézomib 1,5mg/m2 days 1,4,8,11

Cycles 2, 3, 4 :

* Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
* Bortézomib 1,5mg/m2 days 1,4,8,11

Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles

Responding patients may continue the treatment for 2 further cycles

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

Primary outcomes:
measure: Complete Response
measure: Partial Response
measure: Efficacy and safety evaluation
timeFrame: 18 mois
Secondary outcomes:
measure: Hematological Improvement
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: CHU de Caen
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Albert Michallon
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: Hopital Paoli Calmette
city: Nice
country: France
facility: CHU Archet
city: Paris
country: France
facility: Hopital Cochin
city: Perpignan
country: France
facility: Centre Hospitalier Joffre
city: Rouen
country: France
facility: Centre Henry Becquerel
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de STRASBOURG
city: Toulouse
country: France
facility: CHU Purpan
city: Vandoeuvre
country: France
facility: CHU Brabois
Study officials:
affiliation: Groupe francaise des Myelodysplasies
name: Francois DREYFUS, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: