Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma (MDX1411-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730652
Recruitment Status : Withdrawn (Sponsor Decision)
First Posted : August 8, 2008
Last Update Posted : April 22, 2010
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma. Biological: MDX-1411 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
Study Start Date : May 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: 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.
Biological: 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.

Primary Outcome Measures :
  1. Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) [ Time Frame: Day 1-40 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730652

Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Medarex Medical Monitor Medarex

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00730652     History of Changes
Other Study ID Numbers: MDX1411-02
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: April 2010

Keywords provided by Bristol-Myers Squibb:
Medarex Inc.

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin