Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.
Conditions
Keywords
Medarex Inc.
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.
Interventions
BIOLOGICALMDX-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.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) | Day 1-40 |
Outcome results
None listed