Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

NCT ID: NCT00730652

Last Updated: 2010-04-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-03-31

Brief Summary

To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.

Detailed Description

Dose-escalation, multidose study of MDX-1411, a fully human nonfucosylated monoclonal antibody (mAb) targeting the CD70 transmembrane cell-surface protein, which is highly expressed in B-cell malignancies such as CLL and MCL.

Conditions

Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDX1411

An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.

Group Type: EXPERIMENTAL

MDX-1411

Intervention Type: BIOLOGICAL

Single dose of MDX-1411 (fully human monoclonal antibody) will be administered as an intravenous (i.v.) infusion every 7 days for up to a total of 5 doses.

Interventions

MDX-1411

Single dose of MDX-1411 (fully human monoclonal antibody) will be administered as an intravenous (i.v.) infusion every 7 days for up to a total of 5 doses.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy;
• Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy
• For MCL, must have measurable disease
• At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL;
• At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411
• ECOG Performance Status 0 to 2;
• No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C;

Exclusion Criteria

• History of severe hypersensitivity reactions to other monoclonal antibodies;
• Use of other investigational drugs within 30 days before study drug administration
• Prior treatment with any other anti-CD70 antibody;
• Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411;
• Evidence of bleeding diathesis or coagulopathy;
• Active autoimmune disease requiring immunosuppressive therapy;
• Known current drug or alcohol abuse;
• Underlying medical conditions that will make the administration of MDX-1411 hazardous

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Medarex Medical Monitor

Role: STUDY_DIRECTOR

Medarex

Other Identifiers

MDX1411-02

Identifier Type: -

Identifier Source: org_study_id