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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00593944
First received: January 3, 2008
Last updated: May 21, 2013
Last verified: May 2013

January 3, 2008
May 21, 2013
August 2008
May 2010   (final data collection date for primary outcome measure)
incidence and severity of treatment-emergent adverse events [ Time Frame: all events will be followed to resolution ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00593944 on ClinicalTrials.gov Archive Site
  • 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 ]
  • vital sign measurements [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  • clinical laboratory tests [ Time Frame: study duratation - each visit ] [ Designated as safety issue: No ]
  • immunogenicity evaluations [ Time Frame: first and last dose of drug and during follow up ] [ Designated as safety issue: No ]
  • ECOG evaluation [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  • physical examination [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  • electrocardiogram [ Time Frame: at screening and study completion ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
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.
Experimental: 1
Patients will receive active MDX-1342.
Intervention: Biological: MDX-1342
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00593944
MDX1342-02, IM130-002
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP