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A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Phase II Pilot Study of Brentuximab Vedotin, Rituximab and Dose Attenuated CHP in Elderly Patients With DLBCL

NCT02734771•Patrick Reagan

View on ClinicalTrials.gov

Summary

This is a study incorporating brentuximab vedotin and dose attenuated rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the overlapping toxicities with brentuximab vedotin.

Detailed Description

This is a multicenter, single-arm pilot study incorporating brentuximab vedotin and dose attenuated rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) into initial therapy for elderly patients with DLBCL. Vincristine will be omitted from the standard R-CHOP regimen given the overlapping toxicities with brentuximab vedotin. CD30 positivity will be determined at enrollment and patients will be enrolled into a CD30 positive and negative group in equal numbers. Additionally, a Comprehensive Geriatric Assessment (CGA) will be performed on all patients, but this will not be used to guide treatment decisions.

Eligibility

Age

75 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary written informed consent before performance of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Subjects must be able to understand and be willing to sign the written informed consent form.
•Men and women aged greater than or equal to 75 years of age
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
•Histologically-confirmed DLBCL by World Health Organization classification by site hematopathologist
•* Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT must not have received an anthracycline-containing regimen in the past.
•* Composite lymphoma containing both indolent and large cell features will be included
•Has received no prior therapy for DLBCL or HT with the exception of a course of prednisone of less than or equal to 7 days given for lymphoma related symptoms; prior therapy for follicular lymphoma is accepted, but no prior anthracycline-containing therapy.
•Carriers of hepatitis B virus should be closely monitored for clinical and laboratory signs of active hepatitis B virus infection and for signs of hepatitis throughout study participation.
•Total bilirubin must be less than 1.5 times the upper limit of normal (ULN) unless the elevation is known to be due to Gilbert syndrome.
•Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be less than 3 times the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of DLBCL in liver.

Exclusion Criteria

•Patient has a platelet count of ≤50,000/mm3 within 14 days before enrollment.
•Patient has an absolute neutrophil count of \< 1,000/mm3 within 14 days before enrollment.
•Patient has a calculated or measured creatinine clearance of \<30 mL/minute within 14 days before enrollment.
•Patient is receiving peritoneal dialysis or hemodialysis
•Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
•Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
•New York Heart Association class III heart failure or ejection fraction of less than 30% on echocardiogram or Multi Gated Acquisition Scan (MUGA)
•Patient has received other investigational drugs with 14 days before enrollment
•Prior exposure to anthracycline
•Patient has concomitant active malignancy that the treating physician or PI feels may interfere with the ability to measure the primary or secondary outcomes
+7 more criteria

Locations (2)

James P. Wilmot Cancer Institute, University of Rochester Medical Center

Rochester, New York, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

August 12, 2025

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

Brentuximab vedotin

DRUG

Rituximab

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Prednisone

DRUG

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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: August 12, 2025Data 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 Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Inclusion Criteria

Exclusion Criteria

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