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

NCT00108108 | Terminated Phase 1

• 1 other identifier: CHCD122A2101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• to determine the maximum tolerated dose (MTD)

  between study Day 1 and study Day 50

Secondary Outcomes (4)

• to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients

  between study Day 1 and study termination

• To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients

  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

  between study Day 1 and study termination

• To assess preliminary anti-tumor activity of HCD122 in dose escalation patients

  between study Day 1 and study termination

Study Arms (1)

HCD122

EXPERIMENTAL

Drug: HCD122

Interventions

HCD122 DRUG

HCD122

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of CLL requiring treatment
• Refractory or relapsed disease
• Prior treatment with fludarabine
• Male or Female
• \>18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• XOMA (US) LLC: collaborator

Study Sites (5)

University of California San Diego StudyCoordinator:CHCD122A2101

La Jolla, California, 92093-0658, United States

Location

St. Francis Cancer Research Foundation

Beech Grove, Indiana, 46107, United States

Location

The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies

Baltimore, Maryland, 21231, United States

Location

OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101

Columbus, Ohio, 43210, United States

Location

MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

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

Interventions

lucatumumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2005
• First Posted: April 15, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 1, 2012

Record last verified: 2012-09

Locations

US (5)