Back to results

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

Primary Purpose

Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MDX-1411

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma. focused on measuring Medarex Inc.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDX1411

Arm Description

An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.

Outcomes

Primary Outcome Measures

Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)

Secondary Outcome Measures

Full Information

NCT ID

NCT00730652

First Posted

August 4, 2008

Last Updated

April 21, 2010

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00730652

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor Decision

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.

Keywords

Medarex Inc.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MDX1411

Arm Type

Experimental

Arm Description

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 Type

Biological

Intervention Name(s)

MDX-1411

Intervention Description

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 Measure Information:

Title

Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)

Time Frame

Day 1-40

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medarex Medical Monitor

Organizational Affiliation

Medarex

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs