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
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia
Both
Chronic Lymphocytic Leukemia
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 |
