Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533748
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SJALL23H Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
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:
This is a Phase II clinical trial testing the use of two antigen-directed therapies inotuzumab and blinatumomab as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma
Primary Objective
To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131
Secondary Objectives
To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17
To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17
To assess the event free and overall survival of patients treated with this therapy
Primary Objective
To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131
Secondary Objectives
To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17
To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17
To assess the event free and overall survival of patients treated with this therapy
Detailed Description:
This study utilizes a single arm phase II design Treatment will consist of 3 main phases Induction early post induction including Consolidation Blinatumomab 1 High-Dose Methotrexate Reinduction Interim Reconsolidation and Blinatumomab 2 and Maintenance
Induction
Induction includes 7 days of therapy on the INITIALL classification protocol NCT06289673 as well as 5 further weeks of treatment on this trial Treatment includes 15 days of oral PO or intravenous IV dexamethasone 3 weekly doses of vincristine IV and 2 doses of inotuzumab IV on Days 2 and 8 Patients will then receive blinatumomab IV from Days 9-36 Dasatinib PO will be added beginning on Day 12 for patients with an ABL-class fusion including patients with Ph ALL These patients will also receive dasatinib in all subsequent cycles of therapy Intrathecal IT MHA will be given Patients will have a week without chemotherapy at the end of Induction although patients with Induction failure MRD 5 disease will proceed directly to consolidation
Early Post Induction
Consolidation will be given following completion of Remission Induction Therapy Patients receive cyclophosphamide intravenous IV cytarabine IV inotuzumab IV and dasatinib PO for patients with ABL-class fusion Patients will have a week without chemotherapy at the end of Consolidation
Blinatumomab 1 will be given for four weeks to all patients after recovery from Consolidation
High-dose Methotrexate will be given IV every two weeks for four cycles Patients will also receive an intrathecal chemotherapy treatment with each of the 2 week cycles and will take oral mercaptopurine continuously if tolerated
Reinduction will consist of dexamethasone for 7 days in the first and third week 3 weekly doses of vincristine IV 1 dose of daunorubicin IV 1 dose of calaspargase IV intrathecal IT MHA one dose and dasatinib PO daily for patients with ABL-class fusion
Interim includes mercaptopurine po daily for 6 weeks dexamethasone for 1 week 5 days daunorubicin and vincristine IV on day 1 of weeks 2 and 5 calaspargase IV on day 1 of weeks 1 and 4 IT MHA on day 1 of week 4 and dasatinib po daily for 6 weeks for patients with ABL-class fusion Patients will have a week without chemotherapy at the end of Interim Therapy Patients with Down syndrome will not receive daunorubicin during this phase
Reconsolidation will repeat therapy given in Consolidation but replace the investigational inotuzumab with traditional mercaptopurine
Blinatumomab 2 will be given for four weeks to patients with elevated end of induction MRD and patients with Down syndrome after Reconsolidation
Maintenance therapy follows Reconsolidation or Blinatumomab 2 for those patients receiving this therapy and includes 8 pulses of dexamethasone and vincristine given every 4 weeks weekly methotrexate daily mercaptopurine intrathecal therapy and dasatinib for patients with ABL-class fusions Maintenance therapy lasts a total of 80 weeks
Duration of therapy is approximately 2ΒΌ years Follow-up is recommended until the patient is in remission for 10 years and is at least 18 years old
Induction
Induction includes 7 days of therapy on the INITIALL classification protocol NCT06289673 as well as 5 further weeks of treatment on this trial Treatment includes 15 days of oral PO or intravenous IV dexamethasone 3 weekly doses of vincristine IV and 2 doses of inotuzumab IV on Days 2 and 8 Patients will then receive blinatumomab IV from Days 9-36 Dasatinib PO will be added beginning on Day 12 for patients with an ABL-class fusion including patients with Ph ALL These patients will also receive dasatinib in all subsequent cycles of therapy Intrathecal IT MHA will be given Patients will have a week without chemotherapy at the end of Induction although patients with Induction failure MRD 5 disease will proceed directly to consolidation
Early Post Induction
Consolidation will be given following completion of Remission Induction Therapy Patients receive cyclophosphamide intravenous IV cytarabine IV inotuzumab IV and dasatinib PO for patients with ABL-class fusion Patients will have a week without chemotherapy at the end of Consolidation
Blinatumomab 1 will be given for four weeks to all patients after recovery from Consolidation
High-dose Methotrexate will be given IV every two weeks for four cycles Patients will also receive an intrathecal chemotherapy treatment with each of the 2 week cycles and will take oral mercaptopurine continuously if tolerated
Reinduction will consist of dexamethasone for 7 days in the first and third week 3 weekly doses of vincristine IV 1 dose of daunorubicin IV 1 dose of calaspargase IV intrathecal IT MHA one dose and dasatinib PO daily for patients with ABL-class fusion
Interim includes mercaptopurine po daily for 6 weeks dexamethasone for 1 week 5 days daunorubicin and vincristine IV on day 1 of weeks 2 and 5 calaspargase IV on day 1 of weeks 1 and 4 IT MHA on day 1 of week 4 and dasatinib po daily for 6 weeks for patients with ABL-class fusion Patients will have a week without chemotherapy at the end of Interim Therapy Patients with Down syndrome will not receive daunorubicin during this phase
Reconsolidation will repeat therapy given in Consolidation but replace the investigational inotuzumab with traditional mercaptopurine
Blinatumomab 2 will be given for four weeks to patients with elevated end of induction MRD and patients with Down syndrome after Reconsolidation
Maintenance therapy follows Reconsolidation or Blinatumomab 2 for those patients receiving this therapy and includes 8 pulses of dexamethasone and vincristine given every 4 weeks weekly methotrexate daily mercaptopurine intrathecal therapy and dasatinib for patients with ABL-class fusions Maintenance therapy lasts a total of 80 weeks
Duration of therapy is approximately 2ΒΌ years Follow-up is recommended until the patient is in remission for 10 years and is at least 18 years old
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