NCT06561074

A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 1 Month – 21 Years
• Healthy volunteers: Not accepted

Summary

To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory 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 relapsed/refractory T-ALL/T-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 5.0. • To summarize the effect of this treatment combination on patients transitioning to Hematopoietic stem cell transplant (HSCT) i.e., 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 cycle(s). 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.

Conditions

• T-cell Acute Lymphoblastic Leukemia
• T-Cell Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Decitabine	Given by vein
DRUG	Venetoclax	Given by mouth
DRUG	Calaspargase pegol-mknl	Given by vein

Timeline

• Start date: 2025-09-25
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2024-08-19
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study