Tailored drug dosing may cut infections after stem cell transplants
NCT ID NCT07648992
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving anti-thymocyte globulin (ATG) based on individual patient levels can reduce viral infections after stem cell transplants from unrelated donors. About 324 patients will receive either personalized or fixed doses of ATG. The goal is to find a dose that prevents graft-versus-host disease without increasing the risk of infections like CMV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-thymocyte globulin (ATG)
- What this could lead to
- If successful, this could lead to a safer, more effective way to prevent graft-versus-host disease and reduce viral infections after stem cell transplants, improving survival.
- What could go wrong
- This is a single-center study in China, and results may not apply to other populations. The approach is still being tested, and balancing infection risk with graft-versus-host disease prevention remains challenging.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 324 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2029
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 65 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with indications for allogeneic hematopoietic stem cell transplantation, with malignant hematologic diseases in CR1 or CR2 before transplantation. 2. Have an HLA-matched sibling, unrelated, or haploidentical donor. 3. Age ≥ 14 years and ≤ 65 years. 4. Liver function: ALT and AST ≤ 2.5 × upper limit of normal, bilirubin ≤ 2 × upper limit of normal. 5. Renal function: creatinine ≤ upper limit of normal. 6. No uncontrolled infection or severe mental or psychological disorders. 7. ECOG performance status score of 0-2. 8. Signed informed consent. Exclusion Criteria: \- 1.No HLA-matched donor. 2.Malignant hematologic disease in CR3 or higher disease stage, or refractory/relapsed status. 3.Patient age \< 14 years or \> 65 years. 4.Pregnancy of either the donor or the recipient. 5.Presence of mental illness or other conditions that preclude compliance with the protocol.
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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, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a bone drug plus immune signal stop blood cancer from returning after transplant?
- Can tailored drug dosing make stem cell transplants safer?
- A phone call from a survivor: could peer support calm transplant anxiety?
- Can gut bacteria help rebuild immunity after stem cell transplants?
- Can a different immune drug cut viral infections after stem cell transplants?
- Can a simple blood test make a key transplant drug safer?