Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287229
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-23
Brief Title:
Phase IbII Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With RelapsedRefractory RR and Newly Diagnosed B-cell Acute Lymphocytic Leukemia ALL Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomabHCVAD-inotuzumab-blinatumomab
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase IbII Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With RelapsedRefractory RR and Newly Diagnosed B-cell Acute Lymphocytic Leukemia ALL Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomabHCVAD-inotuzumab-blinatumomab
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsedrefractory B-cell ALL after treatment with inotuzumab ozogamicin blinatumomab and either hyper-CVAD or mini-hyper-CVD Also to learn if giving brexucabtagene autoleucel to patients with relapsedrefractory or high-risk newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin blinatumomab and either hyper-CVAD or mini-hyper-CVD can help to control the disease
Detailed Description:
Primary Objectives
To assess the Efficacy of Brexucabtagene autoleucel anti-CD19 autologous derived chimeric antigen receptor T-cell CAR-T in terms of EFS in patients with RR and high-risk newly diagnosed B-cell acute lymphoblastic leukemia B-cell ALL post cytoreduction with mini-hyper-CVD-inotuzumab-blinatumomabHyper-CVAD-inotuzumab-blinatumomab
The EFS will be estimated in terms of median EFS and 9-month EFS for the RR cohort and 18-month EFS for the frontline cohort
Secondary Objectives
1 12 and 24-months overall survival OS 12 months for the RR cohort and 24 months for the frontline cohort
2 Duration of persistent MRD negativity by flow cytometry and NGS at 9 and 18 months 9 months for the RR cohort and 18 months for the frontline cohort
3 Best Ooverall response rates complete remission CR and CR with incomplete count recovery CRi
4 Achievement of MRD negativity amongst patients in CR and not MRD negative before Brexucabtagene autoleucel infusion
5 Safety
Exploratory Objectives
1 CAR-T-cell expansion Days 1 4 8 11 14 21 28 monthly up to 3 months and then every 3 months up to 24 months post infusion
2 B-cell aplasia Days 0 7 14 28 monthly up to 3 months and then every 3 months up to 24 months post infusion
3 Measurable residual disease MRD negativity by next-generation sequencing NGS at 1 in 105-6 sensitivity PB on D14 and PBBM Day 28 and then Q3 months up to 24 months post infusion
4 Cytokine panel Days 0 1 2 4 7 10 14 28
5 Additional correlatives samples to address tumor samples and immune system factors will be collected at baseline D28 and Q3 months These include samples for bulk RNA sequencing of the tumor and germline and single cell RNA sequencing of CAR T-cells as also for assessing the methylation signatures of the CAR T-cells
To assess the Efficacy of Brexucabtagene autoleucel anti-CD19 autologous derived chimeric antigen receptor T-cell CAR-T in terms of EFS in patients with RR and high-risk newly diagnosed B-cell acute lymphoblastic leukemia B-cell ALL post cytoreduction with mini-hyper-CVD-inotuzumab-blinatumomabHyper-CVAD-inotuzumab-blinatumomab
The EFS will be estimated in terms of median EFS and 9-month EFS for the RR cohort and 18-month EFS for the frontline cohort
Secondary Objectives
1 12 and 24-months overall survival OS 12 months for the RR cohort and 24 months for the frontline cohort
2 Duration of persistent MRD negativity by flow cytometry and NGS at 9 and 18 months 9 months for the RR cohort and 18 months for the frontline cohort
3 Best Ooverall response rates complete remission CR and CR with incomplete count recovery CRi
4 Achievement of MRD negativity amongst patients in CR and not MRD negative before Brexucabtagene autoleucel infusion
5 Safety
Exploratory Objectives
1 CAR-T-cell expansion Days 1 4 8 11 14 21 28 monthly up to 3 months and then every 3 months up to 24 months post infusion
2 B-cell aplasia Days 0 7 14 28 monthly up to 3 months and then every 3 months up to 24 months post infusion
3 Measurable residual disease MRD negativity by next-generation sequencing NGS at 1 in 105-6 sensitivity PB on D14 and PBBM Day 28 and then Q3 months up to 24 months post infusion
4 Cytokine panel Days 0 1 2 4 7 10 14 28
5 Additional correlatives samples to address tumor samples and immune system factors will be collected at baseline D28 and Q3 months These include samples for bulk RNA sequencing of the tumor and germline and single cell RNA sequencing of CAR T-cells as also for assessing the methylation signatures of the CAR T-cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01756 | OTHER | NCI-CTRP Clinical Registry | None |