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

Phase 1

Completed

• Conditions: Hodgkin's Lymphomas
• Interventions: Biological: MDX-1401

• Registration Number: NCT00634452
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-13
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-05
• Last Update Posted: 2012-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDX-1401	MDX-1401	MDX-1401 iv at various doses

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Profile	Two years

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Day 50
Tumor response assessment	Two year

Trial Locations

Locations (6)

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

ClinWorks Cancer Research Center; 🇺🇸 Charlotte, North Carolina, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Scott and White Memorial Hospital and Clinic; 🇺🇸 Temple, Texas, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States