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

NCT07428486 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-1676NCI-2026-01274
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W

EXPERIMENTAL

5 cycles of the FLAG chemotherapy in combination with lisaftoclax and pelcitoclax

Drug: Fludarabine; Drug: Cytarabine; Drug: G-CSF; Drug: Lisaftoclax; Drug: Pelcitoclax

Interventions

Fludarabine DRUG

Given by IV

Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W

Cytarabine DRUG

Given by IV

Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W

G-CSF DRUG

Given by Injection

Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W

Lisaftoclax DRUG

Given by Po

Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W

Pelcitoclax DRUG

Given by Iv

Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: Age ≥18 years with relapsed or refractory T-cell ALL.
• Performance status ≤2 (ECOG Scale).
• Adequate liver, cardiac, renal and pancreatic function as defined by the following criteria:
• Total serum bilirubin \<2x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<3 x ULN, unless due to the underlying leukemia approved by the PI
• Creatinine clearance ≥30 mL/min
• Ejection fraction ≥40%
• Ability to understand and the willingness to sign a written informed consent document
• Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after completion of study participation. For women of childbearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide.

You may not qualify if:

• Participant s who previously received lisaftoclax or any Bcl-xL inhibitor
• Active and uncontrolled infection
• Active secondary malignancy. Participant s with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI.
• Clinically significant, uncontrolled, active cardiovascular disease, including active grade III-V cardiac failure as defined by the New York Heart Association Criteria
• Prior investigational therapy within 14 days of enrollment, unless the participant has rapidly progressive disease judged to be life-threatening by the investigator. Cytoreduction with corticosteroids and/or hydroxyurea, is permitted.
• Recent exposure to strong inducer of CYP3A or p-glycoprotein within 14 days of study enrollment, or 5 half-lives, whichever is longer. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart
• Pregnant or lactating women
• Inability to swallow
• Unable or unwilling to sign the consent form
• Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection
• o Note: Participants who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Participants who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cytarabine, filgrastim, pegfilgrastim, lisaftoclax, and pelcitoclax or other agents used in study.
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Ascentage Pharma Group Inc.: collaborator

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

fludarabine; Cytarabine; Granulocyte Colony-Stimulating Factor; Lisaftoclax; pelcitoclax

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Nicholas J Short, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 23, 2026
• Study Start: April 27, 2026
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-02

Locations

US (1)