Promising leukemia combo study pulled before starting
NCT ID NCT07428486
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to find safe doses of two experimental drugs (lisaftoclax and pelcitoclax) combined with standard FLAG chemotherapy for adults with T-cell acute lymphoblastic leukemia that returned or didn't respond to treatment. The trial was withdrawn before enrolling any participants, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Started
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Apr 2026
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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