Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT06737250
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL
Sponsor:
NOBO Medicine
Organization:
Study Overview
Official Title:
Open, Single Arm, Multicenter, Phase 2 Trial to Evaluate Efficacy and Safety of NB02 (Poseltinib) Combined with Rituximab and Lenalidomide As a Salvage Therapy for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-12
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:
POTENTIAL-P
Brief Summary:
An Open, Single treatment arm, Multi-center, Prospective, Phase 2 Trial to Evaluate Efficacy and Safety of NB02 (Poseltinib) combined with Rituximab and Lenalidomide as a Salvage Therapy for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
Detailed Description:
For outpatients or inpatients who meet the criteria for subject selection, the study is conducted with patients who have given a sufficient explanation of the study and who voluntarily consented to participate in the study.
Patients enrolled in the study receive a combination therapy of NB02, Rituximab and lenalidomide according to the criteria specified in the protocol.
Induction(R2P) 21 days per cycles, 6 cycles
* NB02 : 60mg BID PO, Day 1-21
* Rituximab 375mg/m2 DAY IV Day 1, 8, 15 at 1st cycle; D1 at 2nd to 6th cycles
* Lenalidomide : 20mg QD PO, Day 1-14
Maintenance(RP) 21 days per cycles, until Progression
* NB02 : 60mg BID PO, Day 1-21
* Lenalidomide : 20mg QD PO, Day 1-14
Patients enrolled in the study receive a combination therapy of NB02, Rituximab and lenalidomide according to the criteria specified in the protocol.
Induction(R2P) 21 days per cycles, 6 cycles
* NB02 : 60mg BID PO, Day 1-21
* Rituximab 375mg/m2 DAY IV Day 1, 8, 15 at 1st cycle; D1 at 2nd to 6th cycles
* Lenalidomide : 20mg QD PO, Day 1-14
Maintenance(RP) 21 days per cycles, until Progression
* NB02 : 60mg BID PO, Day 1-21
* Lenalidomide : 20mg QD PO, Day 1-14
Study Oversight
Has Oversight DMC:
True
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?: