Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722848
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2021-01-20
Brief Title:
Sequential Treatment With Ponatinib and Blinatumomab vs Chemotherapy and Imatinib in Newly Diagnosed Adult Ph ALL
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
Newly Diagnosed Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph ALL Sequential Treatment With Ponatinib and the Bispecific Monoclonal Antibody Blinatumomab vs Chemotherapy and Imatinib
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This is a randomised open-label multicenter phase III study for adult de novo Ph ALL patients based on the combination of Ponatinib with Blinatumomab The control arm will be represented by a chemotherapeutic scheme combined with Imatinib for patients aged 18-65 and by Imatinib plus age-adjusted chemotherapy for elderly patients 65 years old
Patients will be randomized 21 to receive the experimental or control arm If patients in the control arm do not achieve a CHR andor MRD negativity after the sixth consolidation cycle week 20 a crossover to receive Blinatumomab is planned Likewise if patients in the control arm develop an ABL1 mutation at any time of treatment they will switch to experimental arm HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years
After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm patients aged 18-65 will be stratified for transplant allocation
Patients will be randomized 21 to receive the experimental or control arm If patients in the control arm do not achieve a CHR andor MRD negativity after the sixth consolidation cycle week 20 a crossover to receive Blinatumomab is planned Likewise if patients in the control arm develop an ABL1 mutation at any time of treatment they will switch to experimental arm HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years
After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm patients aged 18-65 will be stratified for transplant allocation
Detailed Description:
This is a randomised open-label multicenter phase III study for adult de novo Ph ALL patients 18 years no upper age-limit based on the combination of the pan-TKI Ponatinib with the bispecific monoclonal antibody Blinatumomab The control arm will be represented by a chemotherapeutic scheme combined with Imatinib for patients aged 18-65 and by Imatinib plus age-adjusted chemotherapy for elderly patients 65 years old
Patients 18 years no upper age limit will be randomized 21 to receive the experimental or control arm If patients in the control arm do not achieve a CHR andor MRD negativity after the sixth consolidation cycle week 20 a crossover to receive Blinatumomab is planned Likewise if patients in the control arm develop an ABL1 mutation at any time of treatment they will switch to experimental arm HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years
After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm patients aged 18-65 will be stratified for transplant allocation
Patients 18 years no upper age limit will be randomized 21 to receive the experimental or control arm If patients in the control arm do not achieve a CHR andor MRD negativity after the sixth consolidation cycle week 20 a crossover to receive Blinatumomab is planned Likewise if patients in the control arm develop an ABL1 mutation at any time of treatment they will switch to experimental arm HLA typing will be performed immediately after diagnosis in both arms for patients aged up to 65 years
After the 2 cycles of Blinatumomab in the experimental arm and after consolidation in the control arm patients aged 18-65 will be stratified for transplant allocation
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