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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00593944

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Biological: MDX-1342	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2008

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Patients will receive active MDX-1342.	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.

Arm

Intervention/Treatment

Experimental: 1

Patients will receive active MDX-1342.

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.

Outcome Measures

Primary Outcome Measures

incidence and severity of treatment-emergent adverse events [all events will be followed to resolution]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
2	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
3	Oncology Consultants, PA	Houston	Texas	United States	77024