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

This study has been terminated.
(Slow enrollment and minimal preliminary biological and clinical efficacy.)
Sponsor:
Collaborator:
XOMA (US) LLC
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00108108
First received: April 14, 2005
Last updated: September 28, 2012
Last verified: September 2012
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCD122 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California San Diego StudyCoordinator:CHCD122A2101
La Jolla, California, United States, 92093-0658
United States, Indiana
St. Francis Cancer Research Foundation
Beech Grove, Indiana, United States, 46107
United States, Maryland
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
Baltimore, Maryland, United States, 21231
United States, Ohio
OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
Columbus, Ohio, United States, 43210
United States, Texas
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
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00108108     History of Changes
Other Study ID Numbers: CHCD122A2101
Study First Received: April 14, 2005
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 10, 2014