Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)

NCT ID: NCT00593944

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-05-31

Brief Summary

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

Detailed Description

Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients will receive active MDX-1342.

Group Type: EXPERIMENTAL

MDX-1342

Intervention Type: BIOLOGICAL

MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.

Interventions

MDX-1342

MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• relapsed/refractory CD19-positive CLL
• At least 28 days since prior treatment for CLL
• ECOG PS 0-2
• Screening laboratory values must be met

Exclusion Criteria

• No prior anti-CD19 antibody tx
• No active, uncontrolled infection
• No prior allogeneic bone marrow transplant
• No autoimmune disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Oncology Consultants, PA

Houston, Texas, United States

Countries

United States

Other Identifiers

IM130-002

Identifier Type: OTHER

Identifier Source: secondary_id

MDX1342-02

Identifier Type: -

Identifier Source: org_study_id