Can a new drug combo boost remission in adult leukemia?

NCT ID NCT07795099

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether adding lishatoclax to standard chemotherapy, targeted drugs, or immunotherapies can improve remission rates in adults newly diagnosed with acute lymphoblastic leukemia (ALL). Researchers will enroll 30 patients across three subtypes: Philadelphia chromosome-positive, Philadelphia chromosome-negative, and T-cell ALL. The main goal is to see how many patients achieve complete remission after induction therapy. The study aims to find a more effective and less toxic treatment strategy for ALL.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lishatoclax combined with standard chemotherapy, targeted agents, or immunotherapies
What this could lead to
If it works, this combination could raise remission rates and offer a more effective, less toxic first-line treatment for adults with acute lymphoblastic leukemia.
What could go wrong
This is an early, exploratory study with only 30 participants, so results may not apply broadly. The added drug could also increase side effects or fail to improve outcomes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

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: 1. Newly diagnosed acute lymphoblastic leukemia (ALL) confirmed by bone marrow morphology, immunophenotyping, cytogenetics, and molecular biology according to the WHO 2022 classification criteria. 2. Age ≥ 18 years, male or female. 3. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-2. 4. Life expectancy ≥ 3 months. 5. Males and females of childbearing potential who agree to use effective contraceptive measures. 6. Adequate organ function as defined by the following laboratory parameters: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × ULN; Serum creatinine \< 1.5 × ULN; Serum amylase ≤ 1.5 × ULN; Creatine kinase-MB (CK-MB) ≤ 2 × ULN. 7. Cardiac ejection fraction \> 45% as determined by multigated acquisition (MUGA) scan. 8. Voluntary participation in this clinical trial, with an understanding of the study procedures and the ability to provide written informed consent. Exclusion Criteria: 1. Diagnosis of mixed-phenotype acute leukemia (MPAL) or Burkitt lymphoma/leukemia according to the WHO 2008 classification criteria for tumors of hematopoietic and lymphoid tissues. 2. Concurrent severe and/or uncontrolled underlying diseases, including but not limited to: other malignancies requiring concurrent treatment, acute or chronic hepatitis, severe pancreatic or renal disease, or other life-threatening underlying conditions; presence of severe active infections (e.g., sepsis, active tuberculosis, uncontrolled pneumonia, etc.). 3. Pregnant or lactating women. 4. Positive test for anti-HIV antibodies. 5. Psychiatric disorders that may interfere with the patient's ability to complete the study treatment or provide informed consent. 6. Any condition deemed by the investigator to make the patient unsuitable for enrollment. 7. Inability to swallow capsules or tablets, or presence of gastrointestinal disorders significantly affecting gastrointestinal function and/or inhibiting small intestinal absorption (including malabsorption syndrome, small bowel resection, or poorly controlled inflammatory bowel disease). 8. Known hypersensitivity to the study drug or any of its excipients.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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