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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Biological: MDX-1342

• Registration Number: NCT00593944
• Lead Sponsor: Bristol-Myers Squibb

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Study Start: 2008-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MDX-1342	Patients will receive active MDX-1342.

Primary Outcome Measures

Name	Time	Method
incidence and severity of treatment-emergent adverse events	all events will be followed to resolution

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics sampling	at each dosing visit
response	12 weeks
clinical laboratory tests	study duratation - each visit
physical examination	study duration - each visit
electrocardiogram	at screening and study completion
diagnostic testing	at screening and study completion

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Oncology Consultants, PA; 🇺🇸 Houston, Texas, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States