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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00593944
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : May 22, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Biological: MDX-1342 Phase 1

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  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia
Study Start Date : August 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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.

Primary Outcome Measures :
  1. incidence and severity of treatment-emergent adverse events [ Time Frame: all events will be followed to resolution ]

Secondary Outcome Measures :
  1. response [ Time Frame: 12 weeks ]
  2. clinical laboratory tests [ Time Frame: study duratation - each visit ]
  3. physical examination [ Time Frame: study duration - each visit ]
  4. electrocardiogram [ Time Frame: at screening and study completion ]
  5. diagnostic testing [ Time Frame: at screening and study completion ]
  6. pharmacokinetics sampling [ Time Frame: at each dosing visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00593944

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Texas
Oncology Consultants, PA
Houston, Texas, United States, 77024
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00593944     History of Changes
Other Study ID Numbers: MDX1342-02
IM130-002 ( Other Identifier: BMS )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Bristol-Myers Squibb:
Chronic Lymphocytic Leukemia
B cell

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs