New transplant method aims to cut dangerous immune reaction in half-matched donors
NCT ID NCT05236764
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a stem cell transplant method that removes certain immune cells from the donor's blood to lower the chance of graft-versus-host disease (GvHD), a serious complication. It involves 3 patients with blood cancers or non-cancerous blood disorders who lack a perfectly matched donor. The goal is to see if this filtering approach allows safe transplant without long-term anti-rejection drugs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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May 2026
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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Up to 55 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. Lack of suitable conventional donor (10/10 HLA matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an HLA-matched unrelated donor. This does not include cord blood unit (CBU) availability. 2. Lansky/Karnofsky score \> 50 3. Signed written informed consent 4. Diagnosis of one of the following: 1. Patient with life threatening hematological malignancy including "high-risk" ALL in first complete remission (CR1); ALL in second or subsequent remission (greater than or equal to CR2); high-risk AML in CR1; AML in second or subsequent CR; myelodysplastic syndromes (MDS); non-Hodgkin's lymphomas (NHL) in second or subsequent remission (greater than or equal to CR2); CML 2. Hemophagocytic Lymphohistiocytosis (HLH) including familial HLH, relapsed HLH or central nervous system (CNS) HLH 3. Primary Immunodeficiency Disorders (PID) 4. Hemoglobinopathies including thalassemia or sickle cell disease (SCD) 5. Severe aplastic anemia (SAA) not responding to immune suppressive therapy 6. Congenital/hereditary cytopenias including Fanconi anemia (FA) without malignant clonal evolution (MDA, AML) 7. Other inherited bone marrow failure syndromes (IBMFS) 8. Sever chronic active Epstein Barr virus infection (SCAEBV) with predilection for T-or NK-cell malignancy NOTE: 'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high-risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician. Exclusion Criteria: 1. Life expectancy of less than or equal to 6 weeks 2. Greater than grade II acute graft versus host disease (GVHD) or chronic extensive GVHD due to a previous allograft at the time of inclusion 3. Subject receiving an immunosuppressive treatment for GVHD treatment due to a previous allograft at the time of inclusion 4. Symptomatic cardiac disease or left ventricular shortening fraction less than 25% or ejection fraction \< 40% 5. Severe renal disease, with creatinine clearance \< 40cc/1.73m2 6. Pre-existing severe restrictive pulmonary disease, FVC \< 40% of predicted 7. Severe Hepatic Disease with ALT/AST ≥ x 2.5 upper limit of normal or bilirubin level ≥ x 1.5 upper limit of normal 8. Serious concurrent uncontrolled medical disorder or mental illness 9. Pregnant or breastfeeding female subject 10. Current active infectious disease including viral and fungal diseases at the time of enrollment; that on evaluation of PI precludes ablative chemotherapy or successful transplantation 11. Active HIV infection 12. Severe personality disorder or mental illness that would preclude compliance with 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.
Contacts and locations
Locations
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Gene editing offers hope for a One-Time sickle cell cure
- Half-Matched stem cells tested as a cure for severe aplastic anemia
- New drug takes aim at Treatment-Resistant leukemia
- Half-Matched stem cell transplants tested as a cure path for older aplastic anemia patients
- The immune cells that could make stem cell transplants work better