Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL) (MDX1342-02)

May 21, 2013 updated by: Bristol-Myers Squibb

A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • Texas
      • Houston, Texas, United States, 77024
        • Oncology Consultants, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients will receive active MDX-1342.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence and severity of treatment-emergent adverse events
Time Frame: all events will be followed to resolution
all events will be followed to resolution

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX1342-02
  • IM130-002 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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