Can a children's chemo recipe help adults with leukemia? early trial adds venetoclax to the mix.
NCT ID NCT05386576
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether adding venetoclax to a chemotherapy regimen originally designed for children is safe and effective for adults under 60 with newly diagnosed acute lymphoblastic leukemia (ALL). The study involves 12 participants and focuses on finding the right dose and checking for side effects. It is not yet known if this combination will improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Venetoclax (a targeted drug) combined with standard chemotherapy drugs used in children
- What this could lead to
- If it works, this could point toward a more effective and safer treatment for adults with acute lymphoblastic leukemia.
- What could go wrong
- This is a very early, small trial (12 people) focused on safety, not proof of effectiveness. The combination may cause serious side effects or not work better than existing treatments.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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12 people
The number who actually took part.
- Started
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Jun 2022
- Expected to finish
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May 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 60 years
- 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: * Adult patients with newly diagnosed Philadelphia chromosome (Ph) negative ALL. * Patients with T- or B-cell lymphoblastic lymphoma with no bone marrow involvement will also be eligible for the study. * Age 18-60 * ECOG performance status of 0-2 * Adequate renal function as demonstrated by a calculated creatinine clearance of ≥ 60 ml/min. * Adequate hepatic function as demonstrated by a total bilirubin ≤ 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia) * Patients with central nervous system (CNS) involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days. * Negative serum pregnancy test in women of childbearing potential Exclusion Criteria: * CML in lymphoid blast crisis, mature B-cell (i.e. Burkitt's) lymphoma or mixed phenotype acute leukemia (MPAL) * Prior treatments for ALL, except any doses of corticosteroids and hydroxyurea or one dose of vincristine * Patients who received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment * Unstable angina and/or MI or stroke within 6 months prior to screening, and/or impaired cardiac function with EF \<40% or NYHA class III/IV * Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished. * Patients with HIV or active hepatitis B or hepatitis C infection are ineligible. * Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years.
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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
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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