New combo therapy aims to outsmart leukemia with less poison
NCT ID NCT07643103
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a new way to treat adults newly diagnosed with a specific type of acute lymphoblastic leukemia (Ph-negative B-ALL). Instead of standard high-dose chemotherapy, patients receive a mix of low-dose chemo plus several targeted drugs (inotuzumab ozogamicin, venetoclax, blinatumomab) and possibly CAR-T cell therapy. The goal is to achieve a deep remission with fewer side effects. The study will enroll 32 participants and track how well the cancer responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inotuzumab Ozogamicin, Venetoclax, Blinatumomab, and CD19 CAR-T cells
- What this could lead to
- If successful, this approach could offer a more effective and less toxic first-line treatment for Ph-negative B-ALL, potentially reducing the need for intensive chemotherapy.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 32 participants. The combination may cause unexpected side effects, and results may not apply to all patients. Long-term benefits are not yet known.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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May 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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18 years and older
- 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: 1. Newly diagnosed adult (≥18 years) patients with Ph-negative B-cell acute lymphoblastic leukemia according to WHO 2022 criteria. 2. CD22-positive expression on tumor cells (CD22 ≥20%). 3. Expected survival ≥3 months. 4. Sexually active men and women of childbearing potential must agree to use effective contraception. 5. Ability to understand and voluntarily sign informed consent, and willingness to comply with study requirements. Informed consent must be signed by the patient or a legal next of kin prior to initiation of any study-specific procedures. Exclusion Criteria: 1. Burkitt lymphoma/leukemia. 2. Acute leukemia of ambiguous lineage. 3. Pregnant women. 4. Severe, uncontrolled active infections. 5. History of chronic liver disease (e.g., liver cirrhosis) or prior veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS). 6. History of clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal), or sinus node dysfunction or high-grade atrioventricular (AV) block with chronic bradycardia, unless a permanent pacemaker has been implanted. 7. Uncontrolled active hepatitis B or hepatitis C infection, or known HIV seropositivity. HIV testing may be required according to local regulations or standards. 8. Psychiatric disorders that may impair the subject's ability to complete treatment or provide informed consent. 9. Any other conditions deemed by the investigator to render the subject unsuitable for participation in the study.
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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 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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.