A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia
18 Years
N/A
Both
Chronic Lymphocytic Leukemia
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 Institute | Buffalo, New York 14263 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Oncology Consultants, PA | Houston, Texas 77024 |
