New approach aims to tame immune storms in Half-Matched transplants
NCT ID NCT06828796
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving the immune-suppressing drug tacrolimus earlier than usual can lower the risk of cytokine release syndrome (CRS), a severe inflammatory reaction, in patients receiving a half-matched stem cell transplant for blood cancer. About 20 adults will receive the modified drug schedule. The goal is to make the transplant safer while still controlling the disease.
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 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 80 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: * Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells * Karnofsky status \>/= 70% * Hematologic malignancy requiring allogeneic transplantation * First allogeneic transplant only. Prior autologous transplant is allowed. Exclusion Criteria: * Poor cardiac function: LVEF \<40% * Poor pulmonary function: FEV1 and FVC \<50% predicted * Poor liver function: bilirubin \>/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy) * Poor renal function: Creatinine \>/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) \<40mL/min based on Traditional Cockcroft-Gault formula * Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up
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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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Northside Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Half-Matched stem cell transplants tested as a cure path for older aplastic anemia patients
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children