Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561074
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric Adolescent and Young Adult Patients With RelapsedRefractory T-cell Acute Lymphoblastic Leukemia T-ALL and T- Cell Lymphoblastic Lymphoma T-LLy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric Adolescent and Young Adult Patients With RelapsedRefractory T-cell Acute Lymphoblastic Leukemia T-ALL and T- Cell Lymphoblastic Lymphoma T-LLy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsedrefractory T-ALL and T-LLy The safety of this drug combination will also be studied
Detailed Description:
Primary Objectives
To characterize the clinical efficacy of Calaspargase pegol-mknl and Decitabine in combination with Venetoclax in pediatric adolescent and young adult patients with relapsedrefractory T-ALLT-LLy based upon the complete response rate CR
Secondary Objectives
To summarize efficacy per response rate overall survival OS event free survival EFS and minimal residual disease MRD negativity rate
To summarize the incidence prevalence and severity of adverse drug reactions according to common terminology criteria for adverse events CTCAE NCI CTCAE version 50
To summarize the effect of this treatment combination on patients transitioning to Hematopoietic stem cell transplant HSCT ie number and percentage of patients that are able to proceed to HSCT
To evaluate calaspargase pegol-mknl pharmacokinetics in relapsed refractory patients and investigate its correlation with asparagine levels
Exploratory Objectives
To summarize associations between the genomic alterations in ALL current biomarker expression of the disease with relation to the incidence of proceeding to HSCT in patients with PR or stable disease SD after the induction cycles
To evaluate the effect of anti-PEG and anti-ASP antibodies PEG-ASP on calaspargase enzyme levels and effect of calaspargase pegol-mknl pharmacokinetics on toxicities and treatment outcomes
To characterize the clinical efficacy of Calaspargase pegol-mknl and Decitabine in combination with Venetoclax in pediatric adolescent and young adult patients with relapsedrefractory T-ALLT-LLy based upon the complete response rate CR
Secondary Objectives
To summarize efficacy per response rate overall survival OS event free survival EFS and minimal residual disease MRD negativity rate
To summarize the incidence prevalence and severity of adverse drug reactions according to common terminology criteria for adverse events CTCAE NCI CTCAE version 50
To summarize the effect of this treatment combination on patients transitioning to Hematopoietic stem cell transplant HSCT ie number and percentage of patients that are able to proceed to HSCT
To evaluate calaspargase pegol-mknl pharmacokinetics in relapsed refractory patients and investigate its correlation with asparagine levels
Exploratory Objectives
To summarize associations between the genomic alterations in ALL current biomarker expression of the disease with relation to the incidence of proceeding to HSCT in patients with PR or stable disease SD after the induction cycles
To evaluate the effect of anti-PEG and anti-ASP antibodies PEG-ASP on calaspargase enzyme levels and effect of calaspargase pegol-mknl pharmacokinetics on toxicities and treatment outcomes
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