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RecruitingNCT07908888Updated Nov 2, 2026

Efficacy and Safety of Polatuzumab Vedotin, Rituximab Combined With Reduced-dose Cyclophosphamide, Doxorubicin and Prednisone Regimen in the Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma: A Multicenter, Single-arm, Prospective Study

A Phase 4 interventional study of Polatuzumab Vedotin and Rituximab in Diffuse Large B-Cell Lymphoma, sponsored by The First Hospital of Jilin University. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by The First Hospital of Jilin University · Phase 4, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study summary

This is a multicenter, single-arm, prospective study evaluating the efficacy and safety of polatuzumab vedotin and rituximab combined with a reduced-dose regimen of cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) as first-line treatment in elderly, frail patients with diffuse large B-cell lymphoma (DLBCL). The primary objective is to assess the 2-year progression-free survival (PFS) rate. Eligible participants are elderly patients with previously untreated DLBCL who are assessed as frail or with poor tolerance by comprehensive geriatric assessment.

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma
03

In context

Lymphoma, Large B-Cell, Diffuse

1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.

This study's planned enrollment of 26 is below the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
  2. Age >= 75 years; or age >= 65 years with a G8 screening score \<= 14.
  3. Assessed as "frail / poor tolerance" by geriatric assessment during screening, defined as meeting any one of the following: (a) G8 score \<= 14; (b) IADL score \<= 7; (c) >= 5 cumulative Grade 2 comorbidities on CIRS-G; (d) >= 1 system with a Grade 3-4 comorbidity on CIRS-G.
  4. No prior systemic anti-tumor therapy for DLBCL, including chemotherapy, immunotherapy, targeted therapy or radiotherapy.
  5. Adequate major organ function, defined as: (a) Hematologic: (ANC) >= 1.0 x 10\^9/L, (PLT) >= 75 x 10\^9/L; (b) Hepatic: and ALT \<= 3 x (ULN), total \<= 1.5 x ULN; (c) Renal: (Ccr) >= 30 mL/min; (d) Cardiac: (LVEF) within the institutional normal range by echocardiography, or LVEF >= 50%.
  6. Expected survival >= 3 months.
  7. The patient or their legal representative voluntarily participates in the study and signs the written form.

Exclusion criteria

Exclusion Criteria:

  1. Prior anti-tumor therapy directed at DLBCL.
  2. Bone marrow involvement or involvement of immune-privileged sites.
  3. Concurrent other active , or a prior malignancy that in the investigator's judgment may affect the efficacy and safety evaluation of this study.
  4. Currently participating in another interventional clinical study, or receiving other anti-tumor drug therapy that may affect the efficacy assessment of this study.
  5. Uncontrolled active infection.
  6. Severe cardiac, pulmonary, hepatic, renal or other major organ dysfunction that in the investigator's judgment precludes tolerance of the study treatment.
  7. Other conditions considered unsuitable for enrollment by the investigator.
  8. Patients eligible for transplantation.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Pola-R-miniCHP

    Participants receive polatuzumab vedotin and rituximab combined with reduced-dose cyclophosphamide, doxorubicin and prednisone (Pola-R-miniCHP) for 6 cycles, followed by 2 cycles of rituximab consolidation. Each cycle is 21 days.

    Drug: Polatuzumab Vedotin · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Prednisone

Interventions

  • Polatuzumab vedotin administered intravenously on Day 1 of each 21-day cycle for 6 induction cycles.

  • Rituximab administered intravenously on Day 1 of each 21-day cycle during induction and consolidation.

  • Reduced-dose cyclophosphamide administered intravenously on Day 2 of each 21-day cycle during induction.

  • Doxorubicin administered intravenously on Day 2 of each 21-day cycle during induction.

  • Prednisone administered orally on Days 2 to 6 of each 21-day cycle during induction.

06

What researchers measure

Primary outcomes

  1. 2-year progression-free survival (PFS) rate

    Progression-free survival rate at 2 years, defined as the proportion of participants alive and free of disease progression 2 years after the start of treatment. Progression is assessed according to the Lugano 2014 response criteria.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Aug 2029, 34 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 2, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Aug 15, 2029
CompletionEst.
Aug 15, 2029
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07908888
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Aug 15, 2029 (estimated)
Completion
Aug 15, 2029 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drugs tested here: Polatuzumab vedotin · Rituximab · Cyclophosphamide · Doxorubicin · Prednisone

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