Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564038
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
Status:
NOT_YET_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:
Soundtrack-E
Brief Summary:
The purpose of this study is to assess the safety and efficacy of AZD0486 administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies
Detailed Description:
This is open-label multi-center study to evaluate the safety and preliminary efficacy of AZD0486 administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies
This master study currently includes 3 substudies and each substudy focusing on a defined population
Substudy 1 Relapsedrefractory RR Chronic lymphocytic leukaemia CLL Small lymphocytic leukaemia SLL Substudy 2 RR Mantle-cell lymphoma MCL Substudy 3 Large B-cell lymphoma LBCL or RR B-cell non-Hodgkin lymphoma B-NHL not applicable to US
The study will have the following sequential periods
1 Screening period of 28 days
2 Treatment period
3 Follow-up period
This master study currently includes 3 substudies and each substudy focusing on a defined population
Substudy 1 Relapsedrefractory RR Chronic lymphocytic leukaemia CLL Small lymphocytic leukaemia SLL Substudy 2 RR Mantle-cell lymphoma MCL Substudy 3 Large B-cell lymphoma LBCL or RR B-cell non-Hodgkin lymphoma B-NHL not applicable to US
The study will have the following sequential periods
1 Screening period of 28 days
2 Treatment period
3 Follow-up period
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