Promising leukemia combo study pulled before starting

NCT ID NCT07428486

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 The trial was withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Started

Apr 2026

Finished

Apr 2026

Lead sponsor

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

Anyone

Healthy volunteers

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

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.

acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence T-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

More trials for these conditions

Other studies related to the condition(s) this trial covers.