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Main
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Note: This record shows only the 20 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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13 May 2013 |
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Main ID: |
NCT00408928 |
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Date of registration:
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06/12/2006 |
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Primary sponsor: |
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Public title:
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Study on the Safety and Effectiveness of VELCADE® in the Treatment of Graft-Versus-Host Disease
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Scientific title:
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Phase II Trial of VELCADE® (Bortezomib) for Steroid Refractory Acute GVHD |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00408928 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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John Wagner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thomas Jefferson University |
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Key inclusion & exclusion criteria
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Inclusion Criteria: (All criteria must be met)
1. Patients must have undergone an allogeneic HSCT
2. Clinical or histological evidence of AGVHD
3. Has been treated with a minimum of 2mg/kg of methylprednisolone per day or
equivalent dose of steroids and either one of the following:
1. Has had a minimum of 3 days of steroids including the day of assignment and has
progressive disease.
2. Has had a minimum of 7 days of steroids including the day of assignment and has
had no response.
3. AGVHD progresses at anytime when steroids are tapered to less than 2mg/kg/day of
methylprednisolone or its equivalent.
4. Performance status ECOG 0-2
5. Patients must be willing to use contraception if they have childbearing potential
6. Able to give informed consent
7. Patients must be > 18 years of age, with no upper age limit.
Exclusion Criteria: (Any one criteria will exclude patient)
1. Performance status of ECOG >2.
2. >Grade3 peripheral neuropathy at the time of enrollment
3. Patient has a creatinine clearance (calculated or measured) of <30mL/min at the time
of enrollment.
4. Myocardial infarction within 6 months prior to enrollment or has New York Hospital
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities. Prior to study entry , any ECG
abnormality at Screening has to be documented by the investigator/co-investigator as
not medically relevant.
5. Patient has hypersensitivity to bortezomib, boron or mannitol.
6. Female subject is pregnant or breast-feeding.
7. Patient has received other investigational drug within 14 days prior to enrollment.
8. Serious medical or psychiatric illness likely to interfere with participation in this
clinical study or to obtain informed consent.
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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Graft-versus-Host Disease
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Intervention(s)
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Drug: Bortezomib
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Primary Outcome(s)
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Response to Bortezomib (VELCADE®)
[Time Frame: Through 30 days post-treatment]
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Secondary Outcome(s)
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Toxicities Related to Bortezomib (VELCADE®)
[Time Frame: Through 30 days post-traeatment]
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Secondary ID(s)
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04U.177
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2004-19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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