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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

incidence and severity of treatment-emergent adverse events

Outcome Time Frame:

all events will be followed to resolution

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX1342-02

NCT ID:

NCT00593944

Start Date:

August 2008

Completion Date:

May 2010

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • Chronic Lymphocytic Leukemia
  • B cell
  • leukemia
  • lymphocyte
  • antibody
  • monoclonal
  • cancer
  • blood
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Oncology Consultants, PAHouston, Texas  77024