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

Myelodysplastic Syndromes Clinical Trial

Official title:

Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00411905
• Other study ID #: GFM BAR-C-2005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 14, 2006
• Last updated: March 9, 2007
• Start date: June 2006
• Est. completion date: June 2006

Study information

• Verified date: December 2006
• Source: Groupe Francophone des Myelodysplasies
• Contact: Shanti Natarajan-Amé, MD
• Phone: 00 33 3 88 12 76 70
• Email: shanti.ame[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Bortezomib

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hopital Avicenne	Bobigny
France	Institut Bergonie	Bordeaux
France	CHU de Caen	Caen
France	CHU Dijon	Dijon
France	CHU Albert Michallon	Grenoble
France	CHU de Limoges	Limoges
France	Hopital Paoli Calmette	Marseille
France	CHU Archet	Nice
France	Hopital Cochin	Paris
France	Centre Hospitalier Joffre	Perpignan
France	Centre Henry Becquerel	Rouen
France	Centre Hospitalier Universitaire de STRASBOURG	Strasbourg
France	CHU Purpan	Toulouse
France	CHU Brabois	Vandoeuvre

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response
Primary	Partial Response
Secondary	Hematological Improvement