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Completed

NCT Number: NCT00634452

Phase 1 Study of MDX-1401 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).

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Key information

Conditions

Hodgkin's Lymphomas Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDX-1401

Biological

IV weekly for 4 weeks

Primary outcomes

  1. Safety and Tolerability Profile

    Time frame: Two years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Day 50

  2. Tumor response assessment

    Time frame: Two year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: MDX1401-01

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 13, 2008
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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