Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387121
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-03-04
Brief Title:
Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed ElderlyUnfit 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 Low-dose Chemotherapy Combined With Immuno-targeted Drugs in Newly Diagnosed Elderly or Unfit Patients With Ph-negative B-cell Acute Lymphocytic Leukemia A Prospective Single-arm Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 the treatment of Ph-negative Ph- B-cell acute lymphoblastic leukemia B-ALL despite the achievements of chemotherapy and immunotherapy the therapeutic outcomes are unsatisfactory in elderly or unfit patients In recent years tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival In this study we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL aiming to enhance the measurable residual disease MRD-negative complete remission CR rate measured through flow cytometry following induction therapy reduce the risk of relapse and ultimately improve patients overall survival
Detailed Description:
In this open-label single-arm Phase II study prospective clinical trial a total of 53 Ph-negative Ph- B-cell acute lymphoblastic leukemia B-ALL patients will be enrolled The primary endpoint is measurable residual disease MRD-negative complete remission CR rate after induction therapy
The first cycle of induction therapy is administered with Inotuzumab ozogamicin INO Venetoclax VEN and a combination of low-dose chemotherapy The second cycle of induction therapy is Blinatumomab Blino plus VEN regimen Alternatively the first cycle of induction therapy is a combination of VEN and low-dose chemotherapy and the second cycle of induction therapy is methotrexate MTX plus cytarabine Ara-C plus VEN regimen Subsequent consolidation and maintenance therapy consist of low-dose chemotherapy Blino and VEN Patients can receive chimeric antigen receptor T-Cell CAR-T Immunotherapy or allogeneic hematopoietic stem cell transplantation HSCT or receive autologous HSCT whenever possible during their first CR Otherwise they will finish the consolidation chemotherapy Study patients are scheduled for follow-up for at least 5 years after the end of maintenance therapy
The purpose of current study is to determine the efficacy and safety of low-dose chemotherapy combined with immuno-targeted drugs in newly diagnosed elderly or unfit patients with Ph- B-ALL
The first cycle of induction therapy is administered with Inotuzumab ozogamicin INO Venetoclax VEN and a combination of low-dose chemotherapy The second cycle of induction therapy is Blinatumomab Blino plus VEN regimen Alternatively the first cycle of induction therapy is a combination of VEN and low-dose chemotherapy and the second cycle of induction therapy is methotrexate MTX plus cytarabine Ara-C plus VEN regimen Subsequent consolidation and maintenance therapy consist of low-dose chemotherapy Blino and VEN Patients can receive chimeric antigen receptor T-Cell CAR-T Immunotherapy or allogeneic hematopoietic stem cell transplantation HSCT or receive autologous HSCT whenever possible during their first CR Otherwise they will finish the consolidation chemotherapy Study patients are scheduled for follow-up for at least 5 years after the end of maintenance therapy
The purpose of current study is to determine the efficacy and safety of low-dose chemotherapy combined with immuno-targeted drugs in newly diagnosed elderly or unfit patients with Ph- B-ALL
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