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This study has been withdrawn prior to enrollment.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
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 April 14, 2014