New combo therapy aims to boost survival in adult leukemia
NCT ID NCT07495631
First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study is testing a powerful chemotherapy regimen originally designed for children, combined with the targeted drug venetoclax and immunotherapy, in adults aged 14 to 60 with a certain type of acute lymphoblastic leukemia (ALL). The goal is to see if this approach can achieve higher rates of remission and longer survival. Participants will go through several phases of treatment over many months, with the option to add immunotherapy based on their preference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of chemotherapy drugs (vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, methotrexate), venetoclax, and immunotherapy (inotuzumab ozogamicin, blinatumomab)
- What this could lead to
- If successful, this approach could improve remission rates and long-term survival for adults with a hard-to-treat leukemia, potentially offering a more effective treatment option.
- What could go wrong
- This is a small, early-phase study with only 43 participants, so results may not apply to everyone. The intense chemotherapy and immunotherapy can cause serious side effects like infections and organ damage.
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
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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
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About 43 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2030
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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14 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: * Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL * Age ≥14 years, ≤60 years * ECOG performance status ≤2 * Adequate organ function (liver, kidney, cardiac) * For patients of childbearing potential: use of effective contraception * Willing and able to provide informed consent Exclusion Criteria: * Burkitt leukemia/lymphoma * Acute leukemia of ambiguous lineage * Pregnancy or lactation * Severe uncontrolled active infection * History of pancreatitis * Uncontrolled diabetes (HbA1c \>7.5%) * Active gastrointestinal bleeding within 6 months * Arterial/venous thrombosis within 6 months * Known HIV positivity * Severe psychiatric illness hindering compliance * Any other condition deemed unsuitable by the investigator
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Blood Diseases Hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
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