POLAR BEAR - 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

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Schema di trattamento: 

Active Comparator: Arm A - R-mini-CHOP
Cycles 1-6, duration 21 days

- Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
- Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
- Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
- Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6
- Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6

Experimental: Arm B - R-pola-mini-CHP
Cycles 1-6, duration 21 days

- Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
- Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
- Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
- Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6
- Polatuzumab vedotin 1.8 mg/kg i.v day 1 cycles 1-6

Trattamento sperimentale: 

R-pola-mini-CHP

Trattamento di controllo: 

R-mini-CHOP

Obiettivi primari dello studio: 

Progression-free survival (PFS). [ Time Frame: 2 years. ]
The primary end point of this study is PFS. The null hypothesis is that pola-R-mini-CHP is equivalent to R-mini-CHOP. PFS is        defined as the interval between registration date and date of documented progression or lack of response, first relapse, or    death of any cause. Otherwise, patients will be censored at the last date they were known to be alive. For patients with PD as best response, PFS is defined as 1 day.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-003889-14

Data di inserimento: 10.06.2022

Promotore

Nordic Lymphoma Group

Principal Investigator ITALIA

IRCCS Ospedale San Raffaele, Milano

Riferimento: Dr. Andrés J.M. Ferreri

Telefono: 0226437649

Email: ferreri.andres@hsr.it

Localita: Milano