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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hodgkin's Lymphomas

Treatments: Biological: MDX-1401

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634452

CA213-001 (Other Identifier)

MDX1401-01

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

MDX-1401

Experimental group

Description:

MDX-1401 iv at various doses

Treatment:

Biological: MDX-1401