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A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL

NCT01453205•MedImmune LLC

View on ClinicalTrials.gov

Summary

The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL \& Grade III FL
•Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
•Eligible for ASCT
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•Life expectancy of ≥ 12 weeks
•Adequate hematological function

Exclusion Criteria

•Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
•Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
•Prior autologous or allogeneic SCT
•New York Heart Association ≥ Class II congestive heart failure; Clinically significant abnormality on ECG
•History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
•Evidence of active infection
•Documented current central nervous system involvement by leukemia or lymphoma

Locations (81)

Research Site

Birmingham, Alabama, United States

Research Site

Burbank, California, United States

Research Site

Palm Springs, California, United States

Research Site

Sylmar, California, United States

Research Site

Atlanta, Georgia, United States

Research Site

Westwood, Kansas, United States

Research Site

Hazard, Kentucky, United States

Research Site

Lafayette, Louisiana, United States

Research Site

Shreveport, Louisiana, United States

Research Site

Baltimore, Maryland, United States

Key Dates

Start Date

February 27, 2012

Primary Completion Date

July 11, 2016

Completion Date

July 11, 2016

Last Updated

March 12, 2018

Enrollment

187

ACTUAL participants

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

MEDI-551 2 mg/kg

DRUG

Rituximab

DRUG

ICE

DRUG

DHAP

DRUG

Autologous Stem Cell Transplant (ASCT)

PROCEDURE

MEDI-551 4 mg/kg

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE3

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+5 more

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: March 12, 2018Data 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.

View ClinicalTrials.gov Terms and Conditions

A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Long-term Follow up Local Registry Study of Kymriah in South Korea

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms