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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Biological: MDX-1342


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will receive active MDX-1342. | Biological: MDX-1342<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of treatment-emergent adverse events |  | all events will be followed to resolution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response |  | 12 weeks | 
| clinical laboratory tests |  | study duratation - each visit | 
| physical examination |  | study duration - each visit | 
| electrocardiogram |  | at screening and study completion | 
| diagnostic testing |  | at screening and study completion | 
| pharmacokinetics sampling |  | at each dosing visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLL, Chronic Lymphocytic Leukemia, B cell, leukemia, lymphocyte, antibody, monoclonal, cancer, blood