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

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HCD122
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Diego StudyCoordinator:CHCD122A2101
  • St. Francis Cancer Research Foundation
  • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
  • OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
  • MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HCD122

Arm Description

Outcomes

Primary Outcome Measures

to determine the maximum tolerated dose (MTD)

Secondary Outcome Measures

to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
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
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients

Full Information

First Posted
April 14, 2005
Last Updated
September 28, 2012
Sponsor
Novartis Pharmaceuticals
Collaborators
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00108108
Brief Title
Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and minimal preliminary biological and clinical efficacy.
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
XOMA (US) LLC

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCD122
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HCD122
Primary Outcome Measure Information:
Title
to determine the maximum tolerated dose (MTD)
Time Frame
between study Day 1 and study Day 50
Secondary Outcome Measure Information:
Title
to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
Time Frame
between study Day 1 and study termination
Title
To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
Time Frame
between study Day 1 and study termination
Title
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
Title
To assess preliminary anti-tumor activity of HCD122 in dose escalation patients
Time Frame
between study Day 1 and study termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Diego StudyCoordinator:CHCD122A2101
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
St. Francis Cancer Research Foundation
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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