Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504186
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
The Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After AutologousAllogeneic Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-arm Clinical Study of the Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After AutologousAllogeneic Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
To explore the efficacy and safety ofblinatumomab TKI in B-ALL patients aged 14 years with NGS-MRD relapse sensitivity 10-6 after autoallo HSCT and to observe the disease-free survival DFS recurrence rate and toxicity after transplantation
Detailed Description:
To explore the efficacy and safety ofblinatumomab TKI in B-ALL patients aged 14 years with NGS-MRD relapse sensitivity 10-6 after autoallo HSCT and to observe the disease-free survival DFS recurrence rate and toxicity after transplantation
Primary endpoint disease-free survival DFS recurrence rate Secondary endpoints NGS-MRD response rate overall survival OS incidence of acute and chronic GVHD and summary and evaluation of physical examination vital signs adverse events concomitant treatments and laboratory abnormalities
Ph-negative B-ALL bephedolumab 45 kg 9 mcgd D1-2 28 mcgd D3-14 or 28 mcgd D1-14 45 kg 5 mgm2d D1-2 15 mgm2d D3-14 in 28-day cycles for 3 cycles
Ph-positive B-ALL treatment with bephytoin TKIs bephytoin 45 kg 9 mcgd D1-2 28 mcgd D3-14 or 28 mcgd D1-14 45 kg 5 mgm2d D1-2 15 mgm2d D3-14 in 28-day cycles for 3 cycles
Premedication with dexamethasone
3For adults premedication with dexamethasone 20 mg was administered 1 hour prior to the first dose of each cycle ofblinatumomab prior to dose escalation eg Cycle 1 Day 8 and when the infusion was restarted 4 hours or more after treatment interruption
4Pediatric patients were pre-treated with dexamethasone 5 mgm2 up to a maximum of 20 mg prior to the first dose ofblinatumomabduring Cycle 1 prior to dose escalation eg Cycle 1 Day 8 and when the infusion was resumed 4 hours or more after interruption of therapy during Cycle 1
Primary endpoint disease-free survival DFS recurrence rate Secondary endpoints NGS-MRD response rate overall survival OS incidence of acute and chronic GVHD and summary and evaluation of physical examination vital signs adverse events concomitant treatments and laboratory abnormalities
Ph-negative B-ALL bephedolumab 45 kg 9 mcgd D1-2 28 mcgd D3-14 or 28 mcgd D1-14 45 kg 5 mgm2d D1-2 15 mgm2d D3-14 in 28-day cycles for 3 cycles
Ph-positive B-ALL treatment with bephytoin TKIs bephytoin 45 kg 9 mcgd D1-2 28 mcgd D3-14 or 28 mcgd D1-14 45 kg 5 mgm2d D1-2 15 mgm2d D3-14 in 28-day cycles for 3 cycles
Premedication with dexamethasone
3For adults premedication with dexamethasone 20 mg was administered 1 hour prior to the first dose of each cycle ofblinatumomab prior to dose escalation eg Cycle 1 Day 8 and when the infusion was restarted 4 hours or more after treatment interruption
4Pediatric patients were pre-treated with dexamethasone 5 mgm2 up to a maximum of 20 mg prior to the first dose ofblinatumomabduring Cycle 1 prior to dose escalation eg Cycle 1 Day 8 and when the infusion was resumed 4 hours or more after interruption of therapy during Cycle 1
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