NCT07428486

A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL.

Detailed description

Primary Objectives • To establish the minimum safe and biologically-effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy Secondary Objectives * To determine the CR/CRi rate of the combination regimen * To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry and clonoSEQ, relapse-free survival, overall survival, event-free survival) * To determine the safety of the combination regimen

Conditions

• Phase I
• FLAG Chemotherapy
• Lisaftoclax
• Pelcitoclax
• Relapsed/Refractory
• Lymphoblastic Leukemia Acute

Interventions

Type	Name	Description
DRUG	Fludarabine	Given by IV
DRUG	Cytarabine	Given by IV
DRUG	G-CSF	Given by Injection
DRUG	Lisaftoclax	Given by Po
DRUG	Pelcitoclax	Given by Iv

Timeline

• Start date: 2026-08-17
• Primary completion: 2030-06-12
• Completion: 2032-06-12
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study