NCT05268003

A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia

Detailed description

OBJECTIVES The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia. Primary Objective: To assess complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax. Secondary Objectives: To assess the safety of the regimen To assess rate of measurable residual disease (MRD) negative remission To assess duration of response (DOR), progression-free survival (PFS) and overall survival (OS) Exploratory Objectives: To assess the level of phospho-LCK in pretreatment samples and correlation with the To assess expression of BCL-2 family proteins

Conditions

• Acute Lymphoblastic Leukemia
• Leukemia

Interventions

Type	Name	Description
DRUG	Ponatinib	Given by PO
DRUG	Venetoclax	Given by PO
DRUG	Mini-hyper CVD	Given by IV (vein)

Timeline

• Start date: 2022-06-07
• Primary completion: 2026-10-05
• Completion: 2026-10-05
• First posted: 2022-03-07
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study