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

NCT02734771 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: ULYM15105IST-2014-100578
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

DLBCL

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects Completing Regimen

  Number of subjects who complete all 6 cycles of the therapy divided by the total number of subjects.

  20 weeks

Secondary Outcomes (4)

• Overall Survival

  2 years

• Progression Free Survival

  2 years

• Overall Response Rate

  20 weeks

• Complete Response Rate

  20 weeks

Other Outcomes (8)

• Number of participants with impairment in physical function

  20 weeks

• mean number of falls per participant

  20 weeks

• Mean change in objective physical performance

  baseline and 20 weeks

Study Arms (1)

BV+mini-R-CHP

EXPERIMENTAL

Brentuximab vedotin 1.8 mg/kg IV day 1 for six cycles Rituximab 375 mg/m2 IV day 1 for six cycles Cyclophosphamide 400 mg/m2 IV day 1for six cycles Doxorubicin 25 mg/m2 IV day 1 for six cycles Prednisone 40 mg/m1 PO days 1-5 for six cycles

Drug: Brentuximab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

Interventions

Brentuximab vedotin DRUG

Also known as: Adcetris, SGN-35, cAC10-vcMMAE

BV+mini-R-CHP

Rituximab DRUG

Also known as: Rituxan, Mabthera

BV+mini-R-CHP

Cyclophosphamide DRUG

Also known as: Cytoxan, Lyophilizedcytoxan, Endoxan, Neosar, Procytox, Revimmune, Cycloblastin

BV+mini-R-CHP

Doxorubicin DRUG

Also known as: Adriamycin, Doxil, Caelyx, Myocet

BV+mini-R-CHP

Prednisone DRUG

Also known as: Deltasone, Orasone, Adasone, Deltacortisone, Prednisonum

BV+mini-R-CHP

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

You may not qualify if:

• 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
• Patients with a history of curative, surgically treated basal or squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible.
• Patients with a malignancy that has been treated with surgery alone with curative intent will also be excluded, unless the malignancy has been in documented remission without treatment for ≥ 3 years prior to enrollment.
• Patient is known to be HIV positive (test result not required for enrollment).
• History of solid organ transplantation, or post-transplant lymphoproliferative disorder
• Patient has history of allogeneic stem cell transplantation.

Sponsors & Collaborators

• Patrick Reagan: lead
• Seagen Inc.: collaborator

Study Sites (2)

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

Rochester, New York, 14642, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Brentuximab Vedotin; Rituximab; Cyclophosphamide; Doxorubicin; liposomal doxorubicin; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Patrick M Reagan, MD

  Wilmot Cancer Institute, University of Rochester Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Instructor, Hematology/Oncology

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)