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

This study has suspended participant recruitment.
(Clinical Hold)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00593944
First received: January 3, 2008
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • clinical laboratory tests [ Time Frame: study duratation - each visit ] [ Designated as safety issue: Yes ]
  • physical examination [ Time Frame: study duration - each visit ] [ Designated as safety issue: Yes ]
  • electrocardiogram [ Time Frame: at screening and study completion ] [ Designated as safety issue: Yes ]
  • diagnostic testing [ Time Frame: at screening and study completion ] [ Designated as safety issue: No ]
  • pharmacokinetics sampling [ Time Frame: at each dosing visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: February 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593944

Locations
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00593944     History of Changes
Other Study ID Numbers: MDX1342-02, IM130-002
Study First Received: January 3, 2008
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
CLL
Chronic Lymphocytic Leukemia
B cell
leukemia
lymphocyte
 antibody
monoclonal
cancer
blood

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013