Status:
TERMINATED
Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
XOMA (US) LLC
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.
Eligibility Criteria
Inclusion
- Clinical diagnosis of CLL requiring treatment
- Refractory or relapsed disease
- Prior treatment with fludarabine
- Male or Female
- \>18 years of age
Exclusion
- Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
- Clinically significant cardiac dysfunction or other significant organ dysfunction
- Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00108108
Start Date
April 1 2005
End Date
June 1 2008
Last Update
October 1 2012
Active Locations (5)
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1
University of California San Diego StudyCoordinator:CHCD122A2101
La Jolla, California, United States, 92093-0658
2
St. Francis Cancer Research Foundation
Beech Grove, Indiana, United States, 46107
3
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
Baltimore, Maryland, United States, 21231
4
OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
Columbus, Ohio, United States, 43210