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

September 28, 2012 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego StudyCoordinator:CHCD122A2101
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Cancer Research Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
    • Ohio
      • Columbus, Ohio, United States, 43210
        • OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
    • Texas
      • Houston, Texas, United States, 77030-4009
        • MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCD122
Drug: HCD122

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to determine the maximum tolerated dose (MTD)
Time Frame: between study Day 1 and study Day 50
between study Day 1 and study Day 50

Secondary Outcome Measures

Outcome Measure
Time Frame
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
Time Frame: between study Day 1 and study termination
between study Day 1 and study termination
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
Time Frame: between study Day 1 and study termination
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
Time Frame: between study Day 1 and study termination
between study Day 1 and study termination
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients
Time Frame: between study Day 1 and study termination
between study Day 1 and study termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

XOMA (US) LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 14, 2005

First Submitted That Met QC Criteria

April 14, 2005

First Posted (Estimate)

April 15, 2005

Study Record Updates

Last Update Posted (Estimate)

October 1, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHCD122A2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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