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

Completed · Phase 1

Conditions studied: Hodgkin's Lymphomas

In brief

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

Key facts

Study ID

NCT00634452

Run by

Bristol-Myers Squibb

People needed

22

Starts

2008-02-01

Expected to finish

2010-01-01

Last updated by the study team

2012-12-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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