Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570915
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-arm Multicenter Open-label Phase 2 Study to Evaluate Efficacy and Safety of the Daratumumab in T Cell Acute Lymphoblastic Leukemia With Minimal Residual-Positive After Standard Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
T-ALL-2024
Brief Summary:
T-ALL accounts for about 15-25 of Ph-negative ALL and its clinical prognosis is worse than B-ALL The successful application of immunotherapy has brought revolutionary progress to the treatment of ALL But progress in the treatment of T-ALL has been relatively slow Minimal residual disease MRD is a strong prognostic indicator for ALL patients MRD-positive after induction therapy predicts a high risk of relapse The National Comprehensive Cancer Network NCCN considers MRD-positive ALL patients to be at high risk Research in the B-ALL field has demonstrated that immunotherapy has the potential to further clear MRD which in turn translates into survival benefits Daratumumab is a humanized anti-CD38 IgG1 monoclonal antibody that binds to CD38 expressed by tumor cells Apoptosis of tumor cells is induced through a variety of immune-related mechanisms such as complement-dependent cytotoxicity CDC antibody-dependent cell-mediated cytotoxicity ADCC antibody-dependent cytophagocytosis ADCP and FCγ receptors which are currently mainly used in the treatment of multiple myeloma CD38 is highly and stably expressed on the surface of T-ALL cells and its expression was less influenced by the previous treatment Preliminary data from the clinical study of daratumumab combined with BFM bone frame prescription for the treatment of recurrent refractory T ALLNCT03384654 showed that the effectiveness rate ORR was 833 in children and 60 in young adults Compared with the previous historical data the safety and tolerability were significantly improved For T-ALL patients who relapse after allogeneic transplantation and achieve CR with intense chemotherapy but continue to have MRD-positive flow rate daratumumab monotherapy can further clear MRD and achieve the purpose of sustaining CR These studies all demonstrate the potential role of daratumumab in the treatment of T-ALL Based on the current difficulties in the treatment of T-ALL and existing research data we plan to conduct a prospective single-arm open-label phase II clinical study to explore the efficacy and safety of daratumumab for flow minimal residual disease positive T-ALL after standard chemotherapy
Detailed Description:
Daratumumab is administered once a week at a dose of 16 mgkg for a total of 4 times Day181522 in one cycle Conditions patients can use up to two cycles of treatment
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