Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390319
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-25
Brief Title:
Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia ALL Or Lymphoma T-LLY Or Mixed Phenotype Acute Leukemia MPAL
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
SJALL23T Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia ALL Or Lymphoma T-LLY Or Mixed Phenotype Acute Leukemia MPAL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 clinical trial testing whether the addition of one of two chemotherapy agents dasatinib or venetoclax can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia
Primary Objective
To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231
To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231
Secondary Objectives
To assess the event free and overall survival of patients treated with this therapy
To compare grade 4 toxicities event-free survival EFS and overall survival OS of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17
Primary Objective
To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231
To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231
Secondary Objectives
To assess the event free and overall survival of patients treated with this therapy
To compare grade 4 toxicities event-free survival EFS and overall survival OS of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17
Detailed Description:
Patients will be identified in the first 3 days of therapy during their treatment on INITIALL
Treatment will consist of 3 main phases Induction Early Post Induction including Consolidation High-Dose Methotrexate Intensification Interim 1 Reinduction 1 Interim 2 and Reinduction 2 and Maintenance
Induction
Remission Induction includes 3 days of therapy on the INITIALL classification protocol as well as the remainder of a total of 4 weeks of induction treatment on this trial Treatment includes a total of 28 days of dexamethasone 4 weekly doses of vincristine 3 doses of daunorubicin 1 dose of Calaspargase pegol 6 doses of Intrathecal triple therapy IT MHA and one of 3 additional drugs Patients with T-ALL without near-ETP or ETP phenotype hereafter referred to simply as T-ALL will receive 25 days of dasatinib Patients with ETP or near-ETP ALL as well as those with MPAL will receive 14 days of venetoclax Patients with T-LLy will receive bortezomib 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 will receive 2 cycles of BFM-1b therapy a single dose of cyclophosphamide at the start of week 1 4 daily doses of cytarabine in two consecutive weeks and 2 weeks of mercaptopurine separated by a week of nelarabine Patients will have a week without chemotherapy at the end of Consolidation
High-dose Methotrexate will be given for 4 cycles to all patients Patients will also receive an intrathecal chemotherapy treatment with each of the 2-week cycles and will take oral mercaptopurine continuously if tolerated
Intensification will be given to patients with T-ALL or ETP near-ETP This therapy includes a week of nelarabine one week of combination cyclophosphamide and cytarabine and 1 week of rest without chemotherapy
Interim Therapy 1 includes 6 weeks of oral mercaptopurine 2 weeks 5 days of each week of dexamethasone and two doses weeks 1 and 4 of daunorubicin vincristine and calaspargase pegol
Reinduction Therapy 1 will consist of 3 weekly doses of vincristine 1 dose of daunorubicin and calaspargase pegol at the start of the first week and dexamethasone for 7 days in the first and third weeks Patients will also receive the same additional agent received during induction based on immunophenotype
Interim Therapy 2 includes 6 weeks of oral mercaptopurine two doses weeks 1 and 4 of daunorubicin vincristine and calaspargase pegol
Reinduction Therapy 2 will consist of 3 weekly doses of vincristine 1 dose of daunorubicin and calaspargase pegol at the start of the first week and dexamethasone for 7 days in the first and third weeks Patients will also receive the same additional agent received during induction based on immunophenotype
Maintenance therapy
Early Maintenance Therapy follows Reinduction 2 and lasts 31 weeks Patients will receive mercaptopurine and methotrexate interrupted by 1 week of nelarabine week 3 5 cyclophosphamide cytarabine pulses and every 4-week dexamethasone vincristine pulses For the first 32 weeks patients will also receive every 4-week pulses including 5 days of dexamethasone and 1 dose of vincristine Patients will receive low-dose methotrexate in all weeks when they do not receive dexamethasone or vincristine All patients will receive every 4-week intrathecal chemotherapy beginning 4 weeks after the week of nelarabine
Late Maintenance Therapy follows early maintenance and includes daily mercaptopurine weekly methotrexate and every 8-week intrathecal chemotherapy It lasts a total of 44 weeks
Duration of therapy is approximately 2ΒΌ years It is recommended that patients be followed every 4 months for 1 year every 6 months for 1 year and then yearly until the patient is in remission for 10 years and is at least 18 years old
Treatment will consist of 3 main phases Induction Early Post Induction including Consolidation High-Dose Methotrexate Intensification Interim 1 Reinduction 1 Interim 2 and Reinduction 2 and Maintenance
Induction
Remission Induction includes 3 days of therapy on the INITIALL classification protocol as well as the remainder of a total of 4 weeks of induction treatment on this trial Treatment includes a total of 28 days of dexamethasone 4 weekly doses of vincristine 3 doses of daunorubicin 1 dose of Calaspargase pegol 6 doses of Intrathecal triple therapy IT MHA and one of 3 additional drugs Patients with T-ALL without near-ETP or ETP phenotype hereafter referred to simply as T-ALL will receive 25 days of dasatinib Patients with ETP or near-ETP ALL as well as those with MPAL will receive 14 days of venetoclax Patients with T-LLy will receive bortezomib 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 will receive 2 cycles of BFM-1b therapy a single dose of cyclophosphamide at the start of week 1 4 daily doses of cytarabine in two consecutive weeks and 2 weeks of mercaptopurine separated by a week of nelarabine Patients will have a week without chemotherapy at the end of Consolidation
High-dose Methotrexate will be given for 4 cycles to all patients Patients will also receive an intrathecal chemotherapy treatment with each of the 2-week cycles and will take oral mercaptopurine continuously if tolerated
Intensification will be given to patients with T-ALL or ETP near-ETP This therapy includes a week of nelarabine one week of combination cyclophosphamide and cytarabine and 1 week of rest without chemotherapy
Interim Therapy 1 includes 6 weeks of oral mercaptopurine 2 weeks 5 days of each week of dexamethasone and two doses weeks 1 and 4 of daunorubicin vincristine and calaspargase pegol
Reinduction Therapy 1 will consist of 3 weekly doses of vincristine 1 dose of daunorubicin and calaspargase pegol at the start of the first week and dexamethasone for 7 days in the first and third weeks Patients will also receive the same additional agent received during induction based on immunophenotype
Interim Therapy 2 includes 6 weeks of oral mercaptopurine two doses weeks 1 and 4 of daunorubicin vincristine and calaspargase pegol
Reinduction Therapy 2 will consist of 3 weekly doses of vincristine 1 dose of daunorubicin and calaspargase pegol at the start of the first week and dexamethasone for 7 days in the first and third weeks Patients will also receive the same additional agent received during induction based on immunophenotype
Maintenance therapy
Early Maintenance Therapy follows Reinduction 2 and lasts 31 weeks Patients will receive mercaptopurine and methotrexate interrupted by 1 week of nelarabine week 3 5 cyclophosphamide cytarabine pulses and every 4-week dexamethasone vincristine pulses For the first 32 weeks patients will also receive every 4-week pulses including 5 days of dexamethasone and 1 dose of vincristine Patients will receive low-dose methotrexate in all weeks when they do not receive dexamethasone or vincristine All patients will receive every 4-week intrathecal chemotherapy beginning 4 weeks after the week of nelarabine
Late Maintenance Therapy follows early maintenance and includes daily mercaptopurine weekly methotrexate and every 8-week intrathecal chemotherapy It lasts a total of 44 weeks
Duration of therapy is approximately 2ΒΌ years It is recommended that patients be followed every 4 months for 1 year every 6 months for 1 year and then yearly 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?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03015 | REGISTRY | NCI Clinical Trial Registration Program | None |