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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Royal Prince Alfred Hospital
  Camperdown, Australia Recruiting
• Concord Repatriation General Hospital
  Concord, Australia Recruiting
• Liverpool
  Liverpool, Australia Recruiting
• St Vincent's Hospital Melbourne
  Melbourne, Australia Recruiting
• Prince of Wales Hospital
  Randwick, Australia Recruiting
• Sunshine Coast University Hospital
  Sunshine Coast, Australia Recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Mats Jerkeman — Department of Oncology, Skåne University Hospital
• Study coordinator: Mats Jerkeman
• Email: mats.jerkeman@med.lu.se
• Phone: 0046704973507

Similar studies

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

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

  This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.

  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

  This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07072208

• Predicting response to first-line DLBCL treatment using ctDNA and PET/CT

  This project will test whether combining a blood ctDNA test with PET/CT scans after two treatment cycles can predict treatment response in people newly diagnosed with DLBCL who are starting standard first-line therapy.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07070648

• Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL

  A group of elderly patients with newly diagnosed diffuse large B-cell lymphoma will try a lighter chemotherapy approach using three targeted drugs to see if it works and is safe.

  Recruiting Phase 2 Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07012980

• Pola‑R‑GemOx chemotherapy for relapsed/refractory DLBCL in patients who cannot have an autologous transplant

  This trial will test whether adding polatuzumab vedotin to rituximab, gemcitabine, and oxaliplatin helps people with relapsed or refractory DLBCL who are not eligible for autologous stem‑cell transplant.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07001540

• Treatment for elderly patients with DLBCL who can't tolerate chemotherapy

  This study is testing a new combination treatment for older patients with diffuse large B-cell lymphoma who can't handle traditional chemotherapy to see if it can help them.

  Recruiting Phase 2 First Affiliated Hospital of Ningbo University · Ningbo, Zhejiang · NCT06758037

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.