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

This study has been withdrawn prior to enrollment.
(Sponsor Decision)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00730652
First received: August 4, 2008
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) [ Time Frame: Day 1-40 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 34
Study Start Date: May 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730652

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00730652     History of Changes
Other Study ID Numbers: MDX1411-02
Study First Received: August 4, 2008
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Bristol-Myers Squibb:
Medarex Inc.

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

ClinicalTrials.gov processed this record on July 20, 2014