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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00108108
• Collaborator: XOMA (US) LLC (Industry)
• Enrollment: 26
• Locations: 5
• Arm: 1
• Duration (Months): 38
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: HCD122	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCD122	Drug: HCD122

Outcome Measures

Primary Outcome Measures

1. to determine the maximum tolerated dose (MTD) [between study Day 1 and study Day 50]

Secondary Outcome Measures

1. to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients [between study Day 1 and study termination]

2. To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients [between study Day 1 and study termination]

3. 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]

4. To assess preliminary anti-tumor activity of HCD122 in dose escalation patients [between study Day 1 and study termination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent	Houston	Texas	United States	77030-4009

Sponsors and Collaborators

• Novartis Pharmaceuticals
• XOMA (US) LLC

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
• Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00108108
• Other Study ID Numbers: CHCD122A2101
• First Posted: Apr 15, 2005
• Last Update Posted: Oct 1, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Novartis Pharmaceuticals: Lymphocytic Leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Oct 1, 2012