Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955261
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-06-20
Brief Title:
A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
Status:
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 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia AML
Primary Objectives
Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML
Estimate the proportion of patients who become minimal residual disease MRD negative by flow cytometry after one course of venetoclax-based induction therapy
Secondary Objectives
- Estimate the rates of complete remission CR event-free survival EFS and overall survival OS in pediatric patients who receive venetoclax-based chemotherapy
Primary Objectives
Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML
Estimate the proportion of patients who become minimal residual disease MRD negative by flow cytometry after one course of venetoclax-based induction therapy
Secondary Objectives
- Estimate the rates of complete remission CR event-free survival EFS and overall survival OS in pediatric patients who receive venetoclax-based chemotherapy
Detailed Description:
Treatment will be based on genetic characteristics and response to therapy Venetoclax will be given with each course of therapy Low-risk patients will receive four courses of chemotherapy and intermediate-risk patients will receive five courses High-risk patients who do not have a suitable stem cell donor or who decline HCT will receive five courses of chemotherapy The definition of suitable stem cell donor and the conditioning regimens used for HCT will be determined by local institutional protocols or guidelines
Intervention
Low Risk
Induction 1 Venetoclax orally PO once daily QD on days -2 to 11 cytarabine intravenously IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 etoposide IV over one hour QD on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6
Induction 2 Venetoclax PO QD on days 1-14 cytarabine IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 and etoposide IV over 1 hour QD on days 1-5
Intensification Venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-4 and mitoxantrone hydrochloride IV over 1 hour QD on days 2-4 during intensification 1 and then venetoclax PO QD on days 1-7 and high-dose cytarabine IV over 3 hours every 12 hours on days 1 3 and 5 during intensification 2 Patients with FLT3 activation receive sorafenib PO QD on days 8-28 during intensification 1 and 2
Intermediate Risk
Induction 1 Venetoclax orally PO once daily QD on days -2 to 11 cytarabine intravenously IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 etoposide IV over one hour QD on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6
Induction 2 Venetoclax PO QD on days 1-14 fludarabine phosphate IV over 30 minutes QD on days 1-5 cytarabine IV over 3 hours QD starting 4 hours after each dose of fludarabine on days 1-5 idarubicin hydrochloride IV over 15 minutes QD on days 3-5 Patients with FLT3 activation receive sorafenib PO QD on days 8-28
Intensification Venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-4 and mitoxantrone hydrochloride IV over 1 hour QD on days 2-4 during intensification 1 venetoclax PO QD on days 1-7 and high-dose cytarabine IV over 3 hours every 12 hours on days 1 3 and 5 during intensification 2 and then venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-5 and etoposide IV over 1 hour QD on days 1-5 during intensification 3 Patients with FLT3 activation receive sorafenib PO QD on days 8-28 during intensification 1-3
High Risk
Induction 1 Venetoclax orally PO once daily QD on days -2 to 11 cytarabine intravenously IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 etoposide IV over one hour QD on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6
Induction 2 Venetoclax PO QD on days 1-14 fludarabine phosphate IV over 30 minutes QD on days 1-5 cytarabine IV over 3 hours QD starting 4 hours after each dose of fludarabine on days 1-5 idarubicin hydrochloride IV over 15 minutes QD on days 3-5 Patients with FLT3 activation receive sorafenib PO QD on days 8-28
Intensification Patients with MRD 01 proceed directly to HCT if donor is available If a donor is not yet available patients with MRD 01 may receive ventoclax PO QD on days 1-21 and azacitidine IV over 30 minutes QD on days 1-5 or venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-5 and etoposide IV over 1 hour QD on days 1-5 Patients with MRD 01 to 1 may receive ventoclax PO QD on days 1-21 and azacitidine IV over 30 minutes QD on days 1-5 or venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-5 and etoposide IV over 1 hour QD on days 1-5 Patients with MRD 1 may receive venetoclax PO QD on days 1-10 azacitidine IV over 30 minutes QD on days 1-5 and high-dose cytarabine IV over 3 hours every 12 hours on days 6 8 and 10 Patients with FLT3 activation receive sorafenib PO QD on days 8-28
Intervention
Low Risk
Induction 1 Venetoclax orally PO once daily QD on days -2 to 11 cytarabine intravenously IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 etoposide IV over one hour QD on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6
Induction 2 Venetoclax PO QD on days 1-14 cytarabine IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 and etoposide IV over 1 hour QD on days 1-5
Intensification Venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-4 and mitoxantrone hydrochloride IV over 1 hour QD on days 2-4 during intensification 1 and then venetoclax PO QD on days 1-7 and high-dose cytarabine IV over 3 hours every 12 hours on days 1 3 and 5 during intensification 2 Patients with FLT3 activation receive sorafenib PO QD on days 8-28 during intensification 1 and 2
Intermediate Risk
Induction 1 Venetoclax orally PO once daily QD on days -2 to 11 cytarabine intravenously IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 etoposide IV over one hour QD on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6
Induction 2 Venetoclax PO QD on days 1-14 fludarabine phosphate IV over 30 minutes QD on days 1-5 cytarabine IV over 3 hours QD starting 4 hours after each dose of fludarabine on days 1-5 idarubicin hydrochloride IV over 15 minutes QD on days 3-5 Patients with FLT3 activation receive sorafenib PO QD on days 8-28
Intensification Venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-4 and mitoxantrone hydrochloride IV over 1 hour QD on days 2-4 during intensification 1 venetoclax PO QD on days 1-7 and high-dose cytarabine IV over 3 hours every 12 hours on days 1 3 and 5 during intensification 2 and then venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-5 and etoposide IV over 1 hour QD on days 1-5 during intensification 3 Patients with FLT3 activation receive sorafenib PO QD on days 8-28 during intensification 1-3
High Risk
Induction 1 Venetoclax orally PO once daily QD on days -2 to 11 cytarabine intravenously IV over 30 minutes every 12 hours on days 1-8 daunorubicin hydrochloride IV over 1 hour QD on days 1 3 and 5 etoposide IV over one hour QD on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on day 6
Induction 2 Venetoclax PO QD on days 1-14 fludarabine phosphate IV over 30 minutes QD on days 1-5 cytarabine IV over 3 hours QD starting 4 hours after each dose of fludarabine on days 1-5 idarubicin hydrochloride IV over 15 minutes QD on days 3-5 Patients with FLT3 activation receive sorafenib PO QD on days 8-28
Intensification Patients with MRD 01 proceed directly to HCT if donor is available If a donor is not yet available patients with MRD 01 may receive ventoclax PO QD on days 1-21 and azacitidine IV over 30 minutes QD on days 1-5 or venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-5 and etoposide IV over 1 hour QD on days 1-5 Patients with MRD 01 to 1 may receive ventoclax PO QD on days 1-21 and azacitidine IV over 30 minutes QD on days 1-5 or venetoclax PO QD on days 1-7 cytarabine IV over 1-2 hours every 12 hours on days 1-5 and etoposide IV over 1 hour QD on days 1-5 Patients with MRD 1 may receive venetoclax PO QD on days 1-10 azacitidine IV over 30 minutes QD on days 1-5 and high-dose cytarabine IV over 3 hours every 12 hours on days 6 8 and 10 Patients with FLT3 activation receive sorafenib PO QD on days 8-28
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-2023-04138 | REGISTRY | NCI Clinical Trial Registration Program | None |