Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma
NCT ID: NCT00634452
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2008-02-29
2010-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MDX-1401
MDX-1401 iv at various doses
MDX-1401
IV weekly for 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MDX-1401
IV weekly for 4 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant
* Bi-measurable disease
* ECOG Performance Status of 0 - 2
* Meet all screening laboratory values
Exclusion Criteria
* History of allogeneic transplant
* Any tumor lesion greater than or equal to 10 cm in diameter
* Any active or chronic significant infection
* Underlying medical condition which will make the administration of MDX- 1401 hazardous
* Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
ClinWorks Cancer Research Center
Charlotte, North Carolina, United States
Scott and White Memorial Hospital and Clinic
Temple, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA213-001
Identifier Type: OTHER
Identifier Source: secondary_id
MDX1401-01
Identifier Type: -
Identifier Source: org_study_id