New transplant method aims to reduce dangerous side effects in blood cancer patients
NCT ID NCT05617625
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests a special stem cell transplant that removes immune T-cells from the donor's blood to lower the risk of graft-versus-host disease (GVHD), a serious complication where the donor cells attack the patient's body. About 50 adults with myelodysplastic syndrome (a blood cancer) will receive chemotherapy followed by the processed transplant. The study is currently suspended, and its main goal is to see if this method reduces GVHD severity and improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD34+ enriched, T-cell depleted stem cell transplant using the CliniMACS system
- What this could lead to
- If successful, this approach could reduce the severity of graft-versus-host disease after stem cell transplants, improving outcomes for patients with myelodysplastic syndrome.
- What could go wrong
- This is a small, early-phase trial that is currently suspended. The procedure carries risks including infection, organ damage, and transplant failure, and it may not work for all patients.
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 50 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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Jun 2033
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 75 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: * Myelodysplastic syndrome (MDS): Refractory anemia/refractory anemia with ring sideroblasts/refractory cytopenia with multilineage anemia (RA/RARS/RCMA) with high-risk cytogenetic features or transfusion dependence, as well as Refractory Anemia with Excess Blasts Type 1 and 2 (RAEB-1 and RAEB-2) * Karnofsky (adult) Performance Status of at least 70% * Adequate organ function measured by: * Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise. * Hepatic: \< 3x upper limit of normal (ULN) aspartate aminotransferase (AST) and: 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant \[e.g., acute myeloid leukemia (AML) Chloroma obstructing the biliary tree\]. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g., patients with paroxysmal nocturnal hemoglobinuria (PNH), Gilbert's disease or other hemolytic disorders. * Renal: serum creatinine: \<1.2 mg/dL (normal range 0.7-1.3) or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \> 5940 mL/min (measured or calculated/estimated). * Pulmonary: asymptomatic or if symptomatic, diffusion capacity of lung for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin). * Willing to participate and must sign an informed consent form Exclusion Criteria: * Pregnant or breast-feeding * Active viral, bacterial or fungal infection * Patient seropositive for human immunodeficiency virus (HIV)-I /II; human T-lymphotropic virus (HTLV)-I /II * Presence of leukemia in the central nervous system (CNS)
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Miami Cancer Institute
Miami, Florida, 33176, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can adding rituximab improve remission in chronic GVHD?
- Can starting anemia drug sooner keep MDS patients off transfusions?
- Blood cancer registry tracks thousands to map disease course
- New drug combination targets Hard-to-Treat blood cancers