New hope for adults with rare leukemia: drug combo shows promise in early trial
NCT ID NCT05157971
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether adding the drug venetoclax to a chemotherapy regimen originally designed for children can be safe and effective for adults aged 18-54 with a specific, aggressive form of B-cell acute lymphoblastic leukemia (Ph-like ALL). The study will enroll 24 participants to find the best dose and watch for side effects. If successful, this approach could offer a more targeted treatment option for this hard-to-treat leukemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax
- What this could lead to
- If this works, it could lead to a more effective and tolerable treatment for adults with a hard-to-treat form of acute lymphoblastic leukemia.
- What could go wrong
- This is a very early phase 1 trial with only 24 participants, so safety and dosing are still being figured out. The combination may cause serious side effects, and it's too soon to know if it will 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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- 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
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18 to 54 years
- Sex
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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 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: * Documented informed consent of the participant and/or legally authorized representative * Age between 18 and 54 years * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Histologically confirmed B-cell ALL according to World Health Organization criteria * Note: Lymphoblastic leukemia is included as long as there is bone marrow involvement * Newly diagnosed disease with \>= 5% blasts in the marrow * White blood cell count less than 25 x 10\^9/L prior to initiation of venetoclax. Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease or underlying leukemia, =\< 3 X ULN) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Aspartate aminotransferase (AST) =\< 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Unless it is related to underlying leukemia * Alanine aminotransferase (ALT) =\< 2.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Unless it is related to underlying leukemia * Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Left ventricular ejection fraction (LVEF) \>= 50% * Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy * Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. (performed within 14 days prior to Day 1 of protocol therapy unless otherwise stated) * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential\* to use an effective method of birth control (non-hormonal) or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only Exclusion Criteria: * Leukemia-based therapy with chemotherapy with the exception of: * Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study * Strong or moderate CYP3A4 inducers within 14 days prior to day 1 of protocol therapy * Subjects who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the first dose of study drug * Live vaccines * Philadelphia chromosome positive (Ph+; t(9;22)), MLL-rearrangement, t(12;21), and t(1;19) * T cell ALL * Class III/IV cardiovascular disability according to the New York Heart Association Classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll * Parenchymal central nervous system (CNS) involvement requiring cranial radiation * Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment * History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Clinically significant uncontrolled illness * Uncontrolled active infection * Other active malignancy * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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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.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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