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

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07428486
Phase
PHASE1
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given by IV
  • Cytarabine — DRUG
    Given by IV
  • G-CSF — DRUG
    Given by Injection
  • Lisaftoclax — DRUG
    Given by Po
  • Pelcitoclax — DRUG
    Given by Iv

Study Details

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

Key Dates

Start date
Apr 27, 2026
Status verified
Feb 2026
Primary completion
Apr 27, 2026
Completion
Apr 27, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W
    5 cycles of the FLAG chemotherapy in combination with lisaftoclax and pelcitoclax

Primary Outcome Measure

Safety and adverse events [ Time Frame: Through study completion; an average of 1 year ]

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