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Comparing two treatments for elderly patients with diffuse large B-cell lymphoma

R-MINI-CHOP Versus R-MINI-CHP in Combination With Polatuzumab-vedotin, as Primary Treatment for Patients With Diffuse Large B-cell Lymphoma, ≥80 Years, or Frail ≥75 Years - an Open Label Randomized Nordic Lymphoma Group Phase III Trial

Phase 3 Interventional Nordic Lymphoma Group · NCT04332822

This study is testing whether a new treatment for elderly patients with diffuse large B-cell lymphoma works better than the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages75 Years and up
SexAll
SponsorNordic Lymphoma Group Research network
Drugs / interventionsrituximab, polatuzumab, cyclophosphamide, doxorubicin
Locations69 sites (Albury and 68 other locations)
Trial IDNCT04332822 on ClinicalTrials.gov

What this trial studies

This phase III, randomized, open-label trial aims to evaluate the effectiveness of R-mini-CHOP versus R-pola-mini-CHP in elderly patients with untreated diffuse large B-cell lymphoma (DLBCL). Participants aged 80 or older, or those aged 75 and frail, will be randomly assigned to receive either the standard treatment or an experimental regimen that includes the immunoconjugate polatuzumab vedotin. The study will take place across multiple countries, with a treatment duration of 18 weeks and follow-up lasting up to 36 months. Enrollment began in Q1 2020, with the trial expected to conclude in Q1 2027.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 80 years or older, or those aged 75 years and frail, with untreated diffuse large B-cell lymphoma.

Not a fit: Patients with severe cardiac disease, CNS involvement, uncontrolled serious infections, or significant liver or renal impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a more effective treatment option for elderly patients with DLBCL, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise with similar treatment approaches, but this specific combination is being evaluated for the first time in this population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
* Histologically confirmed lymphoma belonging to one of the following subtypes:

  1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
  2. follicular lymphoma grade 3B
  3. T-cell/histiocyte-rich LBCL
  4. primary cutaneous DLBCL, leg type
  5. EBV-positive DLBCL, NOS
  6. primary mediastinal LBCL
  7. high grade B-cell lymphoma with MYC/BCL2 rearrangement
* Stage II-IV disease
* At least 1 measurable site of disease (\>1.5 cm long axis)
* No previous treatment for lymphoma
* WHO performance status 0 - 3 (Grade 3 if related to DLBCL)
* Written informed consent

Exclusion Criteria:

* Severe cardiac disease: NYHA grade 3-4
* CNS involvement at diagnosis
* Uncontrolled serious infection
* Impaired liver (transaminases \> 3x normal upper limit or bilirubin \> 1.5 x normal upper limit, unless due to Gilbert´s syndrome) , renal (GFR\<30ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment.
* Absolute neutrophil count (ANC) \<1000 cells/µL or platelets \<100,000 cells/µL, unless due to lymphoma
* Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment
* Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
* Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or HACA against rituximab
* Peripheral neuropathy grade ≥ 2

Where this trial is running

Albury and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DLBCLDiffuse Large B Cell Lymphoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.