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

Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma. Clinical Trial

— MDX1411-02  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00730652
• Other study ID #: MDX1411-02
• Status: Withdrawn
• Phase: Phase 1
• First received: August 4, 2008
• Last updated: April 21, 2010
• Start date: May 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 34
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)		Day 1-40	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm