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New transplant method aims to cut dangerous immune reaction in half-matched donors

NCT ID NCT05236764

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

3 people

The number who actually took part.

Started

Dec 2023

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

Up to 55 years

Sex

Anyone

Healthy volunteers

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

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.

acquired aplastic anemia acute myeloid leukemia aplastic anemia Bone Marrow Failure Disorders bone marrow failure syndrome chronic myelogenous leukemia, BCR-ABL1 positive Cytopenia hemoglobinopathy hemophagocytic syndrome inborn error of immunity inherited hemoglobinopathy Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphohistiocytosis, Hemophagocytic myelodysplastic syndrome Myelodysplastic Syndromes non-Hodgkin lymphoma pancytopenia Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Immunodeficiency Diseases

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.