Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649422
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients a Multicenter Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL a Prospective Multicenter Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 prospective multicenter observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL
Detailed Description:
The 14-day blinatumomab combined with reduced-dose chemotherapy is used for the induction treatment of newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia On day 14 an intrathecal injection of chemotherapy is administered on days 28-35 bone marrow is assessed and patients who do not achieve complete remission are withdrawn from the study Patients with positive minimal residual disease MRD after induction treatment undergo transplant typing and proceed to allogeneic hematopoietic stem cell transplantation Allo-HSCT after early intensification Patients with negative MRD receive alternating treatment with multi-drug combination chemotherapy and blinatumomab for a total of 8 consolidation courses including 3 courses of blinatumomab Maintenance therapy lasts for at least 18 months using the POMP regimen with or without one cycle of blinatumomab every six months Throughout the entire treatment phase at least 12 preventive intrathecal injections are administered
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