Combination therapy aims to keep leukemia in check after transplant
NCT ID NCT07677878
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether adding the drug blinatumomab along with a low dose of donor immune cells (called donor lymphocyte infusion) can help prevent relapse in people with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have already had a stem cell transplant. The treatment is given as maintenance therapy after transplant. The main goal is to see if this approach is safe and improves the chance of staying cancer-free one year later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- blinatumomab and donor lymphocyte infusion
- What this could lead to
- If successful, this combination could help prevent relapse and improve long-term survival for people with high-risk B-ALL after a stem cell transplant.
- What could go wrong
- This is an early phase 1 trial with a small number of participants, so safety and effectiveness are not yet proven. There is a risk of graft-versus-host disease or other serious side effects.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2028
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 70 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: * 1\) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures. 2\) Age: \<70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include: * \>CR1 status * Pre-transplant MRD+ status * Ph-like subtype * KMT2A rearrangement * Other high-risk cytogenetic/genetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders. 8\) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment. 10\) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD). Exclusion Criteria: * 1\) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s). 2\) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD: Patients with active infection or active graft-versus-host disease (GVHD). 4\) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation. 5\) Impaired consent/compliance: Patients unable to provide informed consent or comply with procedures due to psychiatric/neurological disorders. 6\) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks. 7\) Organ dysfunction: * Liver: ALT or AST \> 2.5 × ULN; Total bilirubin \> 2 × ULN * Kidney: Serum creatinine \> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).
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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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Chinese PLA General Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental therapy SNC116 put to the test against Hard-to-Treat leukemia
- Can a Pre-Transplant drug keep leukemia from returning?
- Fighting fat to fight leukemia: could a diet and exercise plan boost chemo?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can donor immune cells be engineered to fight blood cancer?
- Can a Chemo-Antibody combo beat a tough leukemia?