Status:
WITHDRAWN
Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 malignan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00730652
Start Date
May 1 2009
End Date
March 1 2013
Last Update
April 22 2010
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