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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00108108
• Other study ID #: CHCD122A2101
• Status: Terminated
• Phase: Phase 1
• First received: April 14, 2005
• Last updated: September 28, 2012
• Start date: April 2005
• Est. completion date: June 2008

Study information

• Verified date: September 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• HCD122

Locations

Country	Name	City	State
United States	The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies	Baltimore	Maryland
United States	St. Francis Cancer Research Foundation	Beech Grove	Indiana
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	University of California San Diego StudyCoordinator:CHCD122A2101	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine the maximum tolerated dose (MTD)		between study Day 1 and study Day 50	Yes
Secondary	to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients		between study Day 1 and study termination	Yes
Secondary	To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients		between study Day 1 and study termination	No
Secondary	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	No
Secondary	To assess preliminary anti-tumor activity of HCD122 in dose escalation patients		between study Day 1 and study termination	No