A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)
NCT ID: NCT00502112
Last Updated: 2011-10-12
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
13 participants
INTERVENTIONAL
2008-03-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
lintuzumab and lenalidomide
lintuzumab
4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
lenalidomide
10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
Interventions
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lintuzumab
4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
lenalidomide
10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Between 5% and 30% blasts in the bone marrow.
3. Received treatment for cytopenias within 2-months
4. ECOG ≤ 2.
Exclusion Criteria
2. Received chemotherapy/radiotherapy within 4 weeks of study registration.
3. Received prior bone marrow transplant.
4. 5q- chromosomal deletion in malignant cells.
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Sievers, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
St.Vincent's Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Ohio State University
Columbus, Ohio, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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SG033-0002
Identifier Type: -
Identifier Source: org_study_id