Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy

Stopped early · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00108108

Run by

Novartis Pharmaceuticals

People needed

26

Starts

2005-04-01

Expected to finish

2008-06-01

Last updated by the study team

2012-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of CLL requiring treatment
• Refractory or relapsed disease
• Prior treatment with fludarabine
• Male or Female
• >18 years of age

You may not qualify if…

• 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.

Where it is running

• University of California San Diego StudyCoordinator:CHCD122A2101 — La Jolla, California, United States
• St. Francis Cancer Research Foundation — Beech Grove, Indiana, United States
• The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies — Baltimore, Maryland, United States
• OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101 — Columbus, Ohio, United States
• MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent — Houston, Texas, United States

Full record on ClinicalTrials.gov

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