A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL

NCT04594798 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ULYM20030
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin in combination with R-miniCHP in patients 75 years and older with DLBCL.

Conditions

DLBCL; Lymphoma, B-Cell

Keywords

polatuzumab vedotin; rituximab; cyclophosphamide; doxorubicin; prednisone; R-miniCHP; DLBCL; Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Measure of time from study enrollment until progression.

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (1)

• Overall Survival

  From date of enrollment until date of death from any cause up to 24 months

Study Arms (1)

Experimental: Polatuzumab Vedotin and R-CHOP

EXPERIMENTAL

The dose of polatuzumab vedotin for each patient will be 1.8 mg/kg (IV for 21 days)

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

Interventions

Polatuzumab vedotin DRUG

IV 1.8 mg/kg per cycle

Experimental: Polatuzumab Vedotin and R-CHOP

Rituximab DRUG

IV 375 mg/m2 per cycle

Experimental: Polatuzumab Vedotin and R-CHOP

Cyclophosphamide DRUG

IV 400 mg/m2 per cycle

Experimental: Polatuzumab Vedotin and R-CHOP

Doxorubicin DRUG

IV 25 mg/m2 per cycle

Experimental: Polatuzumab Vedotin and R-CHOP

Prednisone DRUG

PO 40 mg/m2 per cycle

Experimental: Polatuzumab Vedotin and R-CHOP

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of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
• ECOG performance status of 0-3
• Histologically-confirmed DLBCL, NOS, NOS, high grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma by 2016 WHO classification by site hematopathologist
• Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy, but must not have received an anthracycline-containing regimen in the past. Patients with Richter's transformation will be eligible.
• Composite and discordant lymphomas containing both indolent and large cell features will be included
• Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions:
• A course of corticosteroids given for lymphoma related symptoms.
• A course of cyclophosphamide or vincristine with or without steroids given for lymphoma related symptoms.
• One cycle of anthracycline containing chemotherapy such as R-CHOP or R-miniCHOP given urgently for aggressive disease.
• Patient is not felt to be a candidate for standard dose R-CHOP due to age or comorbidities, per the site investigator.
• Ejection fraction of ≥ 45% on echocardiogram or MUGA
• Patient has a platelet count of ≥75,000/μL within 14 days before enrollment unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma
• Patient has an absolute neutrophil count of ≥1,500/ μL within 14 days before enrollment unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma
• Patient has a calculated or measured creatinine clearance of \>30 mL/minute within 14 days before enrollment.

You may not qualify if:

• History of, or clinically apparent central nervous system (CNS) lymphoma
• Primary mediastinal B-cell lymphoma or EBV positive DLBCL
• Patient is receiving peritoneal dialysis or hemodialysis
• Patient has \> Grade 1 peripheral neuropathy.
• New York Heart Association class III heart failure or EF \<45%
• Patient has received other investigational drugs with 14 days before enrollment
• Prior exposure to anthracycline except for one cycle of therapy given urgently for lymphoma.
• 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 stage 1 cancers are eligible after definitive treatment.
• Patients with low grade prostate cancer who are managed with observation are eligible.
• Patients with other malignancies that have been treated with curative intent will be included if they are in documented remission without treatment for ≥ 3 years prior to enrollment.
• Patient is known to be HIV positive (test result not required for enrollment).
• Patient has active hepatitis B with a positive surface antigen or viral load. Carriers of hepatitis B virus should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis throughout study participation according to national and local guidelines. Those at high risk of reactivation should be placed on appropriate antiviral therapy as per national guidelines.
• History of solid organ transplantation, or post-transplant lymphoproliferative disorder
• Patient has history of allogeneic stem cell transplantation.

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

polatuzumab vedotin; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone

Condition Hierarchy (Ancestors)

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)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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 Reagan

  University of Rochester

  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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: September 20, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)