Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191978
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-12-19
Brief Title:
A Phase IaIb Open-label Multiple Dose Study to Determine the Recommended Dose Evaluate PKs PDs Safety and Activity of Venetoclax in Combination With Oral DecitabineCedazuridine ASTX727 in Pediatric Patients With RelapsedRefractory Acute Myeloid Leukemia AML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase IaIb Open-label Multiple Dose Study to Determine the Recommended Dose Evaluate PKs PDs Safety and Activity of Venetoclax in Combination With Oral DecitabineCedazuridine ASTX727 in Pediatric Patients With RelapsedRefractory Acute Myeloid Leukemia AML
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To find a recommended dose of ASTX727 cedazuridinedecitabine in combination with venetoclax for pediatric patients with relapsed AML
Detailed Description:
Primary Objectives
1 To determine the recommended dose of ASTX727 when given in combination with venetoclax in relapsedrefractory RR pediatric participants with acute myeloid leukemia AML
2 To evaluate and describe the toxicities of ASTX727 and venetoclax administered in RR AML pediatric population
3 To characterize the pharmacokinetic PK and pharmacodynamic PD profile of ASTX727 alone and in combination with venetoclax in an RR AML pediatric population
Secondary Objectives
1 To evaluate the potential for drug-drug interactions effect of venetoclax on PK of ASTX727
2 To define preliminary efficacy of ASTX727 when given in combination with venetoclax in pediatric participants Efficacy will be based on Best Overall Response BOR including complete remission CR CR with incomplete blood count recovery CR with incomplete hematologic recovery and partial remission overall survival OS event-free survival EFS and duration of response DOR of pediatric participants treated with this combination
Exploratory Objectives To quantify the number of pediatric participants transitioning to Hematopoietic stem cell transplant HSCT ie CRCRiCRh rate HR
To identify biological markers of response to venetoclax andor its combination with ASTX727 These effects could be at the molecular cellular or cytogenetic level
1 To determine the recommended dose of ASTX727 when given in combination with venetoclax in relapsedrefractory RR pediatric participants with acute myeloid leukemia AML
2 To evaluate and describe the toxicities of ASTX727 and venetoclax administered in RR AML pediatric population
3 To characterize the pharmacokinetic PK and pharmacodynamic PD profile of ASTX727 alone and in combination with venetoclax in an RR AML pediatric population
Secondary Objectives
1 To evaluate the potential for drug-drug interactions effect of venetoclax on PK of ASTX727
2 To define preliminary efficacy of ASTX727 when given in combination with venetoclax in pediatric participants Efficacy will be based on Best Overall Response BOR including complete remission CR CR with incomplete blood count recovery CR with incomplete hematologic recovery and partial remission overall survival OS event-free survival EFS and duration of response DOR of pediatric participants treated with this combination
Exploratory Objectives To quantify the number of pediatric participants transitioning to Hematopoietic stem cell transplant HSCT ie CRCRiCRh rate HR
To identify biological markers of response to venetoclax andor its combination with ASTX727 These effects could be at the molecular cellular or cytogenetic level
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10826 | OTHER | NCI-CTRP Clinical Registry | None |