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COMPLETEDPHASE1

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

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

NCT00634452•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

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

Locations (6)

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

Key Dates

Start Date

February 1, 2008

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

December 6, 2012

Enrollment

ACTUAL participants

Conditions

Hodgkin's Lymphomas

Interventions

MDX-1401

BIOLOGICAL

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies

NCT02846935

T-cell LymphomaAggressive B-cell Lymphoma+2 more

View study

TERMINATEDPHASE3

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

NCT01732926

Indolent Non-Hodgkin's Lymphomas

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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