Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237192
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-03
Brief Title:
MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Sponsor:
National Research Center for Hematology Russia
Organization:
National Research Center for Hematology Russia
Study Overview
Official Title:
Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
Status:
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:
Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia No high-dose methotrexate MTX and high-dose cytarabine ARA-C consolidation blocks L-asparaginaseis scheduled for 1 year of treatment 21 intrathecal injections through the whole treament T-ALL patients in complete remission CR with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax 56 days and B-ALL patients in complete remission CR with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative by flow cytometry by aberrant immunophenotype in a centralized lab status was achieved
Detailed Description:
7 days prednisolone prephase
8 weeks induction with de-escalation of induction chemotherapy 3 instead of 4 daunovncr pulses
1 instead of 2 Cph injections during induction
2 instead of 4 ARA-C blocks distribution of of L-asp injections through all phases
After CR achievement T-cell ALL and B-ALL patients are being study MRD by FCM MRD-positive patients with T-ALL will receive 1-3 consolidation with venetoclax 400 mgd and B-ALL patients will receive1 additional consolidation by blinatumomab
Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement Rotation of consolidation is permitted
2 years maintenance for all patients
21 TIT through the whole treatment with higher intensity during inductionconsolidation
Centralized MRD monitoring at 70 d 133 d 190 days before and after allo-HSCT
Allo-HSCT is planned only for very high risk patients 11q23 ALL MRD positivity after target therapy ETP T-ALL
8 weeks induction with de-escalation of induction chemotherapy 3 instead of 4 daunovncr pulses
1 instead of 2 Cph injections during induction
2 instead of 4 ARA-C blocks distribution of of L-asp injections through all phases
After CR achievement T-cell ALL and B-ALL patients are being study MRD by FCM MRD-positive patients with T-ALL will receive 1-3 consolidation with venetoclax 400 mgd and B-ALL patients will receive1 additional consolidation by blinatumomab
Non-interruptive 5 consolidation phases with dose modification according to WBC and platelets count after CR achievement Rotation of consolidation is permitted
2 years maintenance for all patients
21 TIT through the whole treatment with higher intensity during inductionconsolidation
Centralized MRD monitoring at 70 d 133 d 190 days before and after allo-HSCT
Allo-HSCT is planned only for very high risk patients 11q23 ALL MRD positivity after target therapy ETP T-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