OncoMatch/Clinical Trials/NCT04332822
A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma
Is NCT04332822 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including R-pola-mini-CHP and R-mini-CHOP for dlbcl.
Treatment: R-pola-mini-CHP · R-mini-CHOP — This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: BCL2 rearrangement
Required: MYC rearrangement
Disease stage
Required: Stage II, III, IV
Performance status
WHO 0–3
Demographics
Prior therapy
Lab requirements
Blood counts
ANC <1000 cells/µL or platelets <100,000 cells/µL, unless due to lymphoma
Kidney function
GFR<30ml/min
Liver function
transaminases > 3x normal upper limit or bilirubin > 1.5 x normal upper limit, unless due to Gilbert´s syndrome
Cardiac function
Severe cardiac disease: NYHA grade 3-4 [excluded]
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. Severe cardiac disease: NYHA grade 3-4
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04332822 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require BCL2?
Yes, BCL2 rearrangement is a required biomarker for enrollment.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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