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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 1-40

Safety Issue:

Yes

Principal Investigator

Medarex Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Medarex

Authority:

United States: Food and Drug Administration

Study ID:

MDX1411-02

NCT ID:

NCT00730652

Start Date:

May 2009

Completion Date:

March 2013

Related Keywords:

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

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