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

Primary Purpose

Chronic Lymphocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MDX-1342

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, Chronic Lymphocytic Leukemia, B cell, leukemia, lymphocyte, antibody, monoclonal, cancer, blood

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Institute
Roswell Park Cancer Institute
Oncology Consultants, PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Patients will receive active MDX-1342.

Outcomes

Primary Outcome Measures

incidence and severity of treatment-emergent adverse events

Secondary Outcome Measures

response

clinical laboratory tests

physical examination

electrocardiogram

diagnostic testing

pharmacokinetics sampling

Full Information

NCT ID

NCT00593944

First Posted

January 3, 2008

Last Updated

May 21, 2013

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00593944

Brief Title

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

Acronym

MDX1342-02

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

Keywords

CLL, Chronic Lymphocytic Leukemia, B cell, leukemia, lymphocyte, antibody, monoclonal, cancer, blood

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Patients will receive active MDX-1342.

Intervention Type

Biological

Intervention Name(s)

MDX-1342

Intervention Description

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.

Primary Outcome Measure Information:

Title

incidence and severity of treatment-emergent adverse events

Time Frame

all events will be followed to resolution

Secondary Outcome Measure Information:

Title

response

Time Frame

12 weeks

Title

clinical laboratory tests

Time Frame

study duratation - each visit

Title

physical examination

Time Frame

study duration - each visit

Title

electrocardiogram

Time Frame

at screening and study completion

Title

diagnostic testing

Time Frame

at screening and study completion

Title

pharmacokinetics sampling

Time Frame

at each dosing visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Oncology Consultants, PA

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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