Bortezomib and Low Dose Cytarabine in the Treatment of High-risk Myelodysplastic Syndromes
NCT ID: NCT00411905
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2006-06-01
2011-08-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Bortezomib
Eligibility Criteria
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Inclusion Criteria
* Life expectancy greater than 6 months
* No other available treatment options
Exclusion Criteria
* \> 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Francois DREYFUS, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Groupe francaise des Myelodysplasies
Locations
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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
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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GFM BAR-C-2005
Identifier Type: -
Identifier Source: org_study_id
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