Spots Global Cancer Trial Database for A Safety Study in Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: A Safety Study in Patients With Chronic Lymphocytic Leukemia
Official Title: A Phase 1/2, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Chronic Lymphocytic Leukemia
Study ID: NCT00283101
Conditions
Interventions
Study Description
Brief Summary: This is an open-label, dose-escalation study to determine the tolerability, safety profile, and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose escalation during the first two weeks regardless of cohort designation.
Detailed Description: A minimum of three patients will be entered into each dose-level cohort for five weeks. Escalation to the next cohort will occur when three patients have received at least one infusion at the highest scheduled dose level, and at least one patient has completed the entire five week dosing schedule. Cohorts will be enrolled at a maximal dose level of 3, 4, 6, or 8 mg/kg/week. Initial therapy will last for 5 weeks. Responding patients will receive additional infusions every two weeks x 4 at the maximal dose for each specific cohort.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Weill Medical College/Cornell University, New York, New York, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Jonathan Drachman, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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