Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846763
Status:
RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-04-27
Brief Title:
Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma RR FL A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2023-04
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 study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with RR FL in a real-world setting in a Chinese population
Detailed Description:
Available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with RR FL but the efficacy and safety in Chinese patients remain to be verified
This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with RR FL in a real-world setting in a Chinese population
The main questions it aims to answer are
To assess the ORR in the RR FL patient population treated with the combination of obinutuzumab and lenalidomide
To assess CRR PFS EFS DOR OS and safety in patients with RR FL treated with the combination of obinutuzumab and lenalidomide
Participants in this study will not and should not result in any intervention to the patients treatment and visits All treatments and visits for patients will be at the physicians discretion according to clinical practice
This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with RR FL in a real-world setting in a Chinese population
The main questions it aims to answer are
To assess the ORR in the RR FL patient population treated with the combination of obinutuzumab and lenalidomide
To assess CRR PFS EFS DOR OS and safety in patients with RR FL treated with the combination of obinutuzumab and lenalidomide
Participants in this study will not and should not result in any intervention to the patients treatment and visits All treatments and visits for patients will be at the physicians discretion according to clinical practice
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?:
None
Is an FDA AA801 Violation?:
None