Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522555
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Pola-ZR2 Polatuzumab Vedotin Zanubrutinib Rituximab and Lenalidomide Versus ZR2 Zanubrutinib Rituximab and Lenalidomide in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma A Multicenter Prospective Randomized Open-label Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multicenter prospective randomized open-label controlled trial to evaluate the efficacy and safety of Pola-ZR2 polatuzumab vedotin zanubrutinib rituximab and lenalidomide versus ZR2 zanubrutinib rituximab and lenalidomide in the treatment of old patients with de novo diffuse large B-cell lymphoma
Detailed Description:
This study will evaluate the efficacy and safety of Pola-ZR2 versus ZR2 in the treatment of elderly de novo diffuse large B-cell lymphoma patients Subjects will be randomly assigned 11 to Pola-ZR2 or ZR2 regimen The stratification will be performed according to international prognostic index 2-3 4-5
Patients in Pola-ZR2 group will receive 6 cycles of polatuzumab vedotin 18 mgkg day 2 on the 1st cycle and day 1 on the 2nd to 6th cycle zanubrutinib 160mg bid day 1-21 orally lenalidomide 25mg qd day 2-11 orally rituximab 375mgm² day 1 intravenously every 21 days Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid day 1-21 orally lenalidomide 25mg qd day 2-11 orally rituximab 375mgm² day 1 intravenously every 21 days
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
Patients in Pola-ZR2 group will receive 6 cycles of polatuzumab vedotin 18 mgkg day 2 on the 1st cycle and day 1 on the 2nd to 6th cycle zanubrutinib 160mg bid day 1-21 orally lenalidomide 25mg qd day 2-11 orally rituximab 375mgm² day 1 intravenously every 21 days Patients in ZR2 group will receive 6 cycles of zanubrutinib 160mg bid day 1-21 orally lenalidomide 25mg qd day 2-11 orally rituximab 375mgm² day 1 intravenously every 21 days
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None