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Could a fixed T-Cell dose make stem cell transplants safer?

NCT ID NCT00959140

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

20 people

The number who actually took part.

Started

Oct 2014

Expected to finish

Dec 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

19 years and older

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. 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

  • University of Alabama Hospital

    Birmingham, Alabama, 35294, United States

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