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
Recruiting now · Phase 3
Conditions studied: DLBCL, Diffuse Large B Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT04332822
- Run by
- Nordic Lymphoma Group
- People needed
- 300
- Starts
- 2020-08-19
- Expected to finish
- 2028-12-28
- Last updated by the study team
- 2024-09-19
Who can join
Age: 75 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment
- Histologically confirmed lymphoma belonging to one of the following subtypes:
- diffuse large B-cell lymphoma, including transformation from an indolent lymphoma
- follicular lymphoma grade 3B
- T-cell/histiocyte-rich LBCL
- primary cutaneous DLBCL, leg type
- EBV-positive DLBCL, NOS
- primary mediastinal LBCL
- 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
You may not qualify if…
- 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 is running
- Kuopio University Hospital — Kuopio, Finland (enrolling)
- Azienda Ospedaliera Univeristaria Federico II di Napoli — Naples, Italy (enrolling)
- Department of Hematology, Zeeland University Hospital Roskilde — Roskilde, Denmark (enrolling)
- Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center — Helsinki, Finland (enrolling)
- Turku University Hospital — Turku, Finland (enrolling)
- Ospedale San Gerardo di Monza — Monza, Italy (enrolling)
- Regionshospitalet Holstebro — Holstebro, Denmark (enrolling)
- Department of Hematology X, Odense University Hospital — Odense, Denmark (enrolling)
- Vejle Sygehus — Vejle, Denmark (enrolling)
- St Vincent's Hospital Melbourne — Melbourne, Australia (enrolling)
- Oulu University Hospital — Oulu, Finland (enrolling)
- Tampere University Hospital — Tampere, Finland (enrolling)
- Centro di riferimento oncologico di Aviano — Aviano, Italy (enrolling)
- Istituto Tumori "Giovanni Paolo II" I.R.C.C.S Bari — Bari, Italy (enrolling)
- Liverpool — Liverpool, Australia (enrolling)
- Prince of Wales Hospital — Randwick, Australia (enrolling)
- Concord Repatriation General Hospital — Concord, Australia (enrolling)
- Sunshine Coast University Hospital — Sunshine Coast, Australia (enrolling)
- Royal Prince Alfred Hospital — Camperdown, Australia (enrolling)
- Westmead — Westmead, Australia (enrolling)
- Department og Hematology, Aalborg University Hospital — Aalborg, Denmark (enrolling)
- Department of Hematology, Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Clinic of Hematology L-4241, Rigshospitalet — Copenhagen, Denmark (enrolling)
- Sydvestjysk Sygehus — Esbjerg, Denmark (enrolling)
- Istituto Nazionale Tumori "Fondazione Pascale" Napoli — Naples, Italy (enrolling)
Full record on ClinicalTrials.gov
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