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
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