The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 29, 2024

Primary Completion Date

August 10, 2028

Study Completion Date

August 10, 2029

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
DRUG

polatuzumab vedotin, zanubrutinib, rituximab and lenalidomide

"Drug: Polatuzumab vedotin, Zanubrutinib, Lenalidomide and Rituximab (Pola-ZR2)~Induction therapy:~The Pola-ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles.~Dosage:~Polatuzumab vedotin 1.8 mg/kg, day 2 on the 1st cycle and day 1 on the 2nd to 6th cycle; Zanubrutinib, 160 mg bid, po, day 1-21; Lenalidomide, 25 mg qd, po, day 2-11; Rituximab, 375 mg/m2, ivgtt, day 1.~Maintenance therapy:~Patients who receive complete response or partial response after induction therapy will receive lenalidomide 25 mg qd po during 1-10 days in every 21 days for 2 years."

DRUG

zanubrutinib, rituximab and lenalidomide

"Drug: Zanubrutinib, Lenalidomide and Rituximab (ZR2)~Induction therapy:~The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles.~Dosage:~Zanubrutinib, 160 mg bid, po, day 1-21; Lenalidomide, 25 mg qd, po, day 2-11; Rituximab, 375 mg/m2, ivgtt, day 1.~Maintenance therapy:~Patients who receive complete response or partial response after induction therapy will receive lenalidomide 25 mg qd po during 1-10 days in every 21 days for 2 years."

Trial Locations (1)

200025

RECRUITING

Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

Ruijin Hospital

OTHER