Could a fixed T-Cell dose make stem cell transplants safer?
NCT ID NCT00959140
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving a fixed number of CD3+ T cells (a type of immune cell) during stem cell transplants from sibling donors leads to more predictable outcomes. Researchers want to see if standardizing the dose reduces variation in complications like graft-versus-host disease. The trial involves 20 patients aged 19 and older.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD3+ T cell depletion (device-based cell selection)
- What this could lead to
- If successful, this could make stem cell transplants more predictable and reduce complications like graft-versus-host disease.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply broadly. The procedure carries risks including infection and graft failure.
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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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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20 people
The number who actually took part.
- Started
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Oct 2014
- Expected to finish
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Dec 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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19 years and older
- 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. Patients must be ≥19 years of age. 2. Patients must meet all the UAB diagnosis and disease status criteria for clinical appropriateness for myeloablative allo HSCT derived from ASBMT and NCCN guidelines. 3. Patients must have a 10/10 HLA matched sibling (excluding identical twin). All donors will be evaluated for eligibility and suitability per standard of care according FACT and NMDP guidelines. 4. Adequate organ function: All organ function testing should be done within 28 days of study registration. 5. Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram. 6. Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted. 7. Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula 8. Performance status: Karnofsky ≥ 70% 9. Hepatic (values to be less than what is considered grade II toxicity per the CTCAE (common terminology criteria for adverse events) Exclusion criteria 1. Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration. 2. HIV positive patients. 3. Prior autologous or allogeneic transplantation for any disease. 4. Scheduled to receive non-myeloablative or reduced intensity conditioning regimen. 5. High Risk Features associated with increased relapse risk or poor outcomes: 1. AML/ALL: with Bi-phenotypic features 2. AML: Refractory to Induction and salvage therapy 3. ALL: Refractory to Induction and salvage therapy 4. CML: Active blast crisis 5. HL: Disease refractory to chemotherapy or targeted therapy 6. NHL: Disease refractory to chemotherapy or targeted therapy
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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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University of Alabama Hospital
Birmingham, Alabama, 35294, United States
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