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

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

NCT07428486•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. Total serum bilirubin \<2x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
•2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<3 x ULN, unless due to the underlying leukemia approved by the PI
•3. Creatinine clearance ≥30 mL/min
•4. 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.

Exclusion Criteria

•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
+3 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 17, 2026

Primary Completion Date

June 12, 2030

Completion Date

June 12, 2032

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Phase IFLAG ChemotherapyLisaftoclaxPelcitoclaxRelapsed/RefractoryLymphoblastic Leukemia Acute

Interventions

Fludarabine

DRUG

Cytarabine

DRUG

G-CSF

DRUG

Lisaftoclax

DRUG

Pelcitoclax

DRUG

Contacts

Nicholas J Short, MD

CONTACT

713-563-4485 nshort@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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