Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma (MDX1411-02)
|ClinicalTrials.gov Identifier: NCT00730652|
Recruitment Status : Withdrawn (Sponsor Decision)
First Posted : August 8, 2008
Last Update Posted : April 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma.||Biological: MDX-1411||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.
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.
- Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) [ Time Frame: Day 1-40 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730652
|Study Director:||Medarex Medical Monitor||Medarex|