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

Phase 1

Terminated

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: HCD122

• Registration Number: NCT00108108
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-04-14
• Study First Submitted QC: 2005-04-14
• Study First Posted: 2005-04-15
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HCD122	HCD122	-

Primary Outcome Measures

Name	Time	Method
to determine the maximum tolerated dose (MTD)	between study Day 1 and study Day 50

Secondary Outcome Measures

Name	Time	Method
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients	between study Day 1 and study termination
To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients	between study Day 1 and study termination
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients	between study Day 1 and study termination
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients	between study Day 1 and study termination

Trial Locations

Locations (5)

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

MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent; 🇺🇸 Houston, Texas, United States

OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101; 🇺🇸 Columbus, Ohio, United States