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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00411905 |
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Date of registration:
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14/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
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Scientific title:
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Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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39 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00411905 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Shanti Natarajan-Amé, MD |
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Address:
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Telephone:
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00 33 3 88 12 76 70 |
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Email:
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shanti.ame@chru-strasbourg.fr |
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Affiliation:
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Name:
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Francois DREYFUS, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Groupe francaise des Myelodysplasies |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myelodysplastic Syndromes
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Intervention(s)
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Drug: Bortezomib
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Primary Outcome(s)
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Complete Response
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Partial Response
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Secondary Outcome(s)
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Hematological Improvement
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Secondary ID(s)
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GFM BAR-C-2005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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