Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma (MDX1411-02)
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ClinicalTrials.gov Identifier: NCT00730652 |
Recruitment Status
:
Withdrawn
(Sponsor Decision)
First Posted
: August 8, 2008
Last Update Posted
: April 22, 2010
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: MDX1411
An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.
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Biological: MDX-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.
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- Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD) [ Time Frame: Day 1-40 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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

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 |
Additional Information:
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00730652 History of Changes |
Other Study ID Numbers: |
MDX1411-02 |
First Posted: | August 8, 2008 Key Record Dates |
Last Update Posted: | April 22, 2010 |
Last Verified: | April 2010 |
Keywords provided by Bristol-Myers Squibb:
Medarex Inc. |
Additional relevant MeSH terms:
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Lymphoma, Non-Hodgkin |