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This study has been withdrawn prior to enrollment.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

August 4, 2008
April 21, 2010
May 2009
December 2012   (final data collection date for primary outcome measure)
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) [ Time Frame: Day 1-40 ] [ Designated as safety issue: Yes ]
maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) [ Time Frame: five infusions every seven days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00730652 on ClinicalTrials.gov Archive Site
Not Provided
best overall response rate (BORR)characterize the immunogenicity, PK and PD of MDX-1411 [ Time Frame: 42 days/cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
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

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

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
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.
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.
Intervention: Biological: MDX-1411
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
34
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00730652
MDX1411-02
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Medarex Medical Monitor Medarex
Bristol-Myers Squibb
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP