Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549595
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Multicentre Randomised Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a global randomised Phase III multicentre open-label study evaluating the efficacy safety and the degree of added benefit of the AZD0486 plus rituximab combination compared to Investigators choice of 3 standard immunochemotherapy regimen conducted in participants with untreated FL
Detailed Description:
The study consists of 2 sequential parts
1 Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D
2 Phase III - The Phase III part will assess the superiority of AZD0486 at RP3D in combination with rituximab compared to Investigators choice between 3 standard chemoimmunotherapy regimens Phase 3 consists of 3 arms
1 Arm A treatment with AZD0486 plus rituximab Schedule A
2 Arm B treatment with AZD0486 plus rituximab Schedule B
3 Arm C Comparator arm one of the following standard regimens per Investigators choice R-CVP rituximab maintenance R-CHOP rituximab maintenance and B-R
1 Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D
2 Phase III - The Phase III part will assess the superiority of AZD0486 at RP3D in combination with rituximab compared to Investigators choice between 3 standard chemoimmunotherapy regimens Phase 3 consists of 3 arms
1 Arm A treatment with AZD0486 plus rituximab Schedule A
2 Arm B treatment with AZD0486 plus rituximab Schedule B
3 Arm C Comparator arm one of the following standard regimens per Investigators choice R-CVP rituximab maintenance R-CHOP rituximab maintenance and B-R
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None