Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma (MDX1401-01)

December 5, 2012 updated by: Bristol-Myers Squibb

A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • ClinWorks Cancer Research Center
    • Texas
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital and Clinic
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry
  • 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:

  • Previous treatment with any other anti-CD30 antibody
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MDX-1401
MDX-1401 iv at various doses
Biological: MDX-1401
IV weekly for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability Profile
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Day 50
Day 50
Tumor response assessment
Time Frame: Two year
Two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX1401-01
  • CA213-001 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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