This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: January 3, 2008
Last updated: May 21, 2013
Last verified: May 2013
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 Intervention Phase
Chronic Lymphocytic Leukemia Biological: MDX-1342 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

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

Enrollment: 15
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00593944     History of Changes
Other Study ID Numbers: MDX1342-02
IM130-002 ( Other Identifier: BMS )
Study First Received: January 3, 2008
Last Updated: May 21, 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 processed this record on August 18, 2017