NCT00730652WithdrawnPhase 1
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
Bristol-Myers Squibb0 sites34 target enrollmentStarted: May 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 34
- Primary Endpoint
- Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
Time Frame: Day 1-40
Secondary Outcomes
No secondary outcomes reported
Investigators
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