Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm, prospective study enrolling elderly patients with previously untreated diffuse large B-cell lymphoma who are considered frail. The regimen combines polatuzumab vedotin and rituximab with a reduced-dose CHOP-like backbone (miniCHP) to form Pola-R-miniCHP as first-line therapy. The primary goal is to determine the 2-year progression-free survival. Eligibility requires age 75 or older, or 65+ with frailty on geriatric assessment, and adequate organ function with no prior systemic anti-tumor therapy for DLBCL. Outcomes will focus on safety and efficacy in this understudied, high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically 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: absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L, platelets (PLT) \>= 75 x 10\^9/L; (b) Hepatic: AST and ALT \<= 3 x upper limit of normal (ULN), total bilirubin \<= 1.5 x ULN; (c) Renal: creatinine clearance (Ccr) \>= 30 mL/min; (d) Cardiac: left ventricular ejection fraction (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 informed consent form.

Exclusion Criteria:

1. Prior anti-tumor therapy directed at DLBCL.
2. Bone marrow involvement or involvement of immune-privileged sites.
3. Concurrent other active malignancy, 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.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for Primary Mediastinal Large B-cell Lymphoma with Antibody Therapy and ImmunoChemotherapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.