Clinical trial NCT00108108: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Keywords: Lymphocytic Leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: XOMA (US) LLC
First posted: 2005-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: to determine the maximum tolerated dose (MTD)
timeFrame: between study Day 1 and study Day 50
Secondary outcomes:
measure: to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients
timeFrame: between study Day 1 and study termination
measure: To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients
timeFrame: between study Day 1 and study termination
measure: 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
timeFrame: between study Day 1 and study termination
measure: To assess preliminary anti-tumor activity of HCD122 in dose escalation patients
timeFrame: between study Day 1 and study termination
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego StudyCoordinator:CHCD122A2101
state: California
city: Beech Grove
country: United States
facility: St. Francis Cancer Research Foundation
state: Indiana
city: Baltimore
country: United States
facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies
state: Maryland
city: Columbus
country: United States
facility: OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: