Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481241
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-05-24
Brief Title:
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL
Sponsor:
Institute of Hematology Blood Diseases Hospital China
Organization:
Institute of Hematology Blood Diseases Hospital China
Study Overview
Official Title:
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
In recent years immunotherapy eg blinatumomab inotuzumab ozogamicin CAR-T cells has demonstrated a high safety and efficacy profile in relapsedrefractory RRB-ALL The available data suggest that the advancement of immunotherapy from relapsedrefractory RR field to the frontline setting may be an important approach to increase the depth of remission which ultimately translates into a survival benefit In this study the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission CR with chemotherapy aiming to reduce the total cycles of chemotherapy and related toxicities shorten length of hospitalization and ultimately improve patients survival and quality of life
Detailed Description:
The CAR-T cells were murine-derived second-generation CD19 CAR-T with a co-stimulation domain of 4-1BB and the infusion dose was 1106kg CAR cells in a single infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None