Viewing Study NCT06176729



Ignite Creation Date: 2024-05-06 @ 7:53 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06176729
Status: RECRUITING
Last Update Posted: 2023-12-20
First Post: 2023-12-05

Brief Title: Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
Sponsor: Yan Zhang MD
Organization: Peking Union Medical College Hospital

Study Overview

Official Title: A Prospective Phase II Study of Polatuzumab Rituximab and LenalidomidePola-R2 in Newly-diagnosed Non-fit Elderly DLBCL Patients
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a prospective single-arm phase II study and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessmentCGA
Detailed Description: In this prospective study all the eligible patients will be given Pola-R2 regimenpolatuzumab vedotin 18 mgkg ivgtt D1 rituximab375 mgm2 ivgtt D1 lenalidomide 25mg po D1-14 one cycle every 21 days An interim evaluation will be performed after 4 cycles the patients who achieve CR or PR will receive another 4 cycles of Pola-R2

The patients with stable disease SD or progressed disease PD will withdraw from the trial and receive salvage regimens

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None