DLBCLPhase 2NCT04594798
A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL
A Phase 2 study testing Polatuzumab vedotin, Rituximab and Cyclophosphamide in people with DLBCL and Lymphoma, B-Cell, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- DLBCL, Lymphoma, B-Cell
- What is being tested?
- Polatuzumab vedotin, Rituximab and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
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- 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.
- 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 or hepatic involvement with aggressive B-cell lymphoma in which case it can be ≤ 3.0 times the ULN.
- ALT or AST must be ≤ 2.5 times the ULN.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 5 months after the last dose of polatuzumab vedotin to avoid exposing the embryo or fetus for the duration of the pregnancy. Men must refrain from donating sperm during this same period.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment.
Who cannot join
- 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
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- 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.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL
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.
Read the detailed description
In this study, the investigator would like to better understand the efficacy and safety of the addition of polatuzumab vedotin to therapy with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) and dose attenuated R-CHOP in patients who are aged 75 years and older.
- Conditions
- DLBCL, Lymphoma, B-Cell
- Being tested
- Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone
- Keywords
- polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, prednisone, R-miniCHP, DLBCL, Lymphoma, B-Cell
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab vedotinDrug
IV 1.8 mg/kg per cycle
RituximabDrug
IV 375 mg/m2 per cycle
CyclophosphamideDrug
IV 400 mg/m2 per cycle
DoxorubicinDrug
IV 25 mg/m2 per cycle
PrednisoneDrug
PO 40 mg/m2 per cycle
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measure of time from study enrollment until progression.
Measured: 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
Measure of time from study enrollment until death from any cause.
Measured: From date of enrollment until date of death from any cause up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start20 Sep 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Patrick Reagan, University of Rochester
- Investigators
- Patrick Reagan, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594798
- Sponsor's protocol ID
- ULYM20030
- Status last verified
- Dec 2025
- First submitted
- 13 Oct 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL
- ClinicalTrials.gov ID
- NCT04594798
- Acronym / sponsor ID
- ULYM20030
- Conditions
- DLBCL, Lymphoma, B-Cell
- Keywords
- polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, prednisone, R-miniCHP, DLBCL, Lymphoma, B-Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigator would like to better understand the efficacy and safety of the addition of polatuzumab vedotin to therapy with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) and dose attenuated R-CHOP in patients who are aged 75 years and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Polatuzumab Vedotin and R-CHOP | Experimental | Drug: Polatuzumab vedotin, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: PrednisoneThe dose of polatuzumab vedotin for each patient will be 1.8 mg/kg (IV for 21 days) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (20 listed)
- 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
- Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions:
Key exclusion criteria (17 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polatuzumab vedotinIV 1.8 mg/kg per cycle | Drug | Experimental: Polatuzumab Vedotin and R-CHOP |
| RituximabIV 375 mg/m2 per cycle | Drug | Experimental: Polatuzumab Vedotin and R-CHOP |
| CyclophosphamideIV 400 mg/m2 per cycle | Drug | Experimental: Polatuzumab Vedotin and R-CHOP |
| DoxorubicinIV 25 mg/m2 per cycle | Drug | Experimental: Polatuzumab Vedotin and R-CHOP |
| PrednisonePO 40 mg/m2 per cycle | Drug | Experimental: Polatuzumab Vedotin and R-CHOP |
Primary outcome
Progression Free Survival
Time frame: 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
Measure of time from study enrollment until progression.
1 secondary outcome
Overall Survival
Time frame: From date of enrollment until date of death from any cause up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Reagan principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polatuzumab vedotin, Rituximab and Cyclophosphamide in people with DLBCL and Lymphoma, B-Cell, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.