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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to determine the maximum tolerated dose (MTD)

Outcome Time Frame:

between study Day 1 and study Day 50

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CHCD122A2101

NCT ID:

NCT00108108

Start Date:

April 2005

Completion Date:

June 2008

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

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