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

Phase 1

Withdrawn

• Conditions: Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
• Interventions: Biological: MDX-1411

• Registration Number: NCT00730652
• Lead Sponsor: Bristol-Myers Squibb

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-08
• Study Start: 2009-05
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-21
• Last Update Posted: 2010-04-22
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 34

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;

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDX1411	MDX-1411	An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.

Primary Outcome Measures

Name	Time	Method
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)	Day 1-40