Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04899453
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2021-05-19
Brief Title:
Intravitreal MTX and ZR Regimen in Newly Diagnosed PVRL
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Combined Intravitreal Methotrexate and ZR Zanubrutinib Rituximab Regimen Followed by Zanubrutinib Maintenance in Newly-diagnosed Primary Vitreoretinal Lymphoma
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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 efficiency of ZR regimen rituximab Zanubrutinib combined with intravitreal methotrexate and followed by Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma Progression-free survival PFS of the cohort is the primary endpoint
Detailed Description:
All the patients will be treated with ZR regimen Rituximab 375mgm2 IV d1 Zanubrutinib 160mg Bid 21 days per cycle as induction regimen meanwhile intravitreal methotrexate was given at a dose of 400ug for 16 doses The response will be evaluated every 3 cycles After 3 Cycles patients who achieved complete remission CR or partial remission PR will receive 3 more cycles of ZR regimen The patients with stable disease SD or progressed disease PD will withdraw from the trial and receive salvage regimens After total 6 induction cycles the investigators evaluate the efficiency again the patients with CR or PR will go to Zanubrutinib maintenance for 2 years or until progression of the disease PD unacceptable toxicity or patientinvestigator discretion And the patients with SD or PD will receive a salvage regimen During following-up surveillance ophthalmologic examination and brain magnetic resonance imaging MRI scans can be performed every 3 months up to the first 2 years followed by the doctor visit every 6 months up to 5 years or the disease relapses
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