Dose-Finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-Responsive to Prior Fludaribine Therapy - Full Text View

Sponsors and Collaborators:	Novartis XOMA (US) LLC
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00108108

Purpose

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	Intervention	Phase
Chronic Lymphocytic Leukemia	Drug: HCD122	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Fludarabine Fludarabine monophosphate Immunoglobulins Globulin, Immune Dacetuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

to determine the maximum tolerated dose (MTD) [ Time Frame: between study Day 1 and study Day 50 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients [ Time Frame: between study Day 1 and study termination ] [ Designated as safety issue: Yes ]
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients [ Time Frame: between study Day 1 and study termination ] [ Designated as safety issue: No ]
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 [ Time Frame: between study Day 1 and study termination ] [ Designated as safety issue: No ]
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients [ Time Frame: between study Day 1 and study termination ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	April 2005
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: HCD122

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108108

Locations

United States, California
UCSD Thorton Hospital and Perlman Cancer Center
La Jolla, California, United States, 92037
United States, Indiana
St. Francis Cancer Research Foundation
Beech Grove, Indiana, United States, 46107
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Novartis

XOMA (US) LLC

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CHCD122A2101
Study First Received:	April 14, 2005
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00108108
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Fludarabine monophosphate
Antibodies, Monoclonal
Leukemia
Signs and Symptoms

Lymphatic Diseases
Antibodies
Leukemia, Lymphocytic, Chronic, B-Cell
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009