Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648889
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Isatuximab in Adult Patients With Cytologic or Molecular RelapsedRefractory CD38 Positive T-cell Acute Lymphoblastic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-arm Phase II Study to Assess the Safety Tolerability and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular RelapsedRefractory CD38 Positive T-cell Acute Lymphoblastic Leukemia GMALL-Isatuximab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The planned trial offers treatment cohorts for patients with full cytologic relapse RR ALL - Cohort 1 as well as for patients with molecular failurerelapse MRD ALL - Cohort 2 Basically the study aims to develop data for optimization of first-line therapy of T-ALL either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies
Detailed Description:
None
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