Hematopoietic Stem Cell TransplantationNCT00959140
Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Related Donors
A study testing CD3+ T cell depletion in people with Hematopoietic Stem Cell Transplantation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Stem cells collected from sibling donors for allogenic transplants contain various types of cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose will benefit the recipient (patient). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- CD3+ T cell depletion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥19 years of age.
- Patients must meet all the UAB diagnosis and disease status criteria for clinical appropriateness for myeloablative allo HSCT derived from ASBMT and NCCN guidelines.
- 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.
- Adequate organ function: All organ function testing should be done within 28 days of study registration.
- Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
- 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.
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- 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
- Performance status: Karnofsky ≥ 70%
- Hepatic (values to be less than what is considered grade II toxicity per the CTCAE (common terminology criteria for adverse events)
Who cannot join
- 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.
- HIV positive patients.
- Prior autologous or allogeneic transplantation for any disease.
- Scheduled to receive non-myeloablative or reduced intensity conditioning regimen.
- High Risk Features associated with increased relapse risk or poor outcomes:
- AML/ALL: with Bi-phenotypic features
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- AML: Refractory to Induction and salvage therapy
- ALL: Refractory to Induction and salvage therapy
- CML: Active blast crisis
- HL: Disease refractory to chemotherapy or targeted therapy
- NHL: Disease refractory to chemotherapy or targeted therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Hospital
Birmingham, Alabama, 35294
About this study
Official title: Phase II Study for Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplants From Matched Related Donors
Stem cells collected from sibling donors for allogenic transplants contain various types of cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose will benefit the recipient (patient). As well as to help discover if dose standardization causes less variation in outcomes between patients and to make transplantation more predictable and complications easier to manage.
Read the detailed description
The optimal CD3+ cell dose to be used for allo HSCT is unknown. In addition, there are multiple variables in addition to CD3+ cell dose which affect engraftment, immune reconstitution, GVH and GVL in these patients including recipient age, diagnosis, disease status at transplantation, donor/recipient tissue type match, preparative regimen, and GVHD prophylaxis. Thus the ability to produce products with a fixed CD3+ content is critical to further research and ultimately to the definition of the "right dose" of CD3+ cells for various clinical situations.
Patients who meet eligibility criteria will receive a peripheral blood stem cell product from their original matched sibling donor engineered to deliver a dose of 3.0+/-0.5 x107 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- CD3+ T cell depletion
- Keywords
- Allo PBSC, HSCT, Bone Marrow Transplant, Allogeneic Bone Marrow Transplant, Matched Related Donor Transplant, MRD HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD3+ T cell depletionDevice
The peripheral blood stem cell product is engineered to deliver a dose of 15 to 20 x10^7 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation. Following collection, CD3+ T cells will be enumerated and a portion of the product containing 15 to 20 x10^7 CD 3+ cells/kg will be set aside. The remainder of the product will be depleted of CD3+ T cells.
Following CD3+ T cell depletion, the CD3+ T cell depleted product will then be combined with the unmanipulated product to provide the specified levels of CD3+ T cells/kg recipient body-weight. The graft is infused into the patient on the same day as selected and within 24 hours of donor aphaeresis.
| Study group | Role | What they receive |
|---|---|---|
| CD3+ T-cell depletion | Experimental | CD3+ T-cell depletion Receives: Device: CD3+ T cell depletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of acute graft versus host disease (aGVHD) with the chosen fixed dose of CD3+ cells
Measured: 1 year
Secondary outcomes (6)
Time to engraftment
Measured: 60 days
State of chimerism over time
Measured: 2 years
Immune reconstitution over time
Measured: 2 years
Incidence, severity and organ involvement with chronic GVHD (cGVHD)
Measured: 2 years
Overall survival
Measured: 2 years
Disease free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startOct 2014
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biotec, Inc.
- Responsible party
- Principal investigator, Antonio Di Stasi, University of Alabama at Birmingham
- Investigators
- Ayman Saad, MD, Principal investigator, University of Alabama in Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959140
- Sponsor's protocol ID
- UAB 1410
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2009
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for Standardization of CD3+ T Cell Dose for Patients Receiving Allogeneic Peripheral Blood Stem Cell Transplants From Matched Related Donors
- ClinicalTrials.gov ID
- NCT00959140
- Acronym / sponsor ID
- UAB 1410
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Allo PBSC, HSCT, Bone Marrow Transplant, Allogeneic Bone Marrow Transplant, Matched Related Donor Transplant, MRD HSCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Miltenyi Biotec, Inc.
- Study start
- Oct 2014 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stem cells collected from sibling donors for allogenic transplants contain various types of cells. The predominant immune cells are called CD3+ T cells. The amount of these T cells vary vastly from donor to donor. This study is to determine if standardizing the CD3+ T cell dose will benefit the recipient (patient). As well as to help discover if dose standardization causes less variation in outcomes between patients and to make transplantation more predictable and complications easier to manage.
Detailed description
The optimal CD3+ cell dose to be used for allo HSCT is unknown. In addition, there are multiple variables in addition to CD3+ cell dose which affect engraftment, immune reconstitution, GVH and GVL in these patients including recipient age, diagnosis, disease status at transplantation, donor/recipient tissue type match, preparative regimen, and GVHD prophylaxis. Thus the ability to produce products with a fixed CD3+ content is critical to further research and ultimately to the definition of the "right dose" of CD3+ cells for various clinical situations.
Patients who meet eligibility criteria will receive a peripheral blood stem cell product from their original matched sibling donor engineered to deliver a dose of 3.0+/-0.5 x107 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD3+ T-cell depletion | Experimental | Device: CD3+ T cell depletionCD3+ T-cell depletion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be ≥19 years of age.
- Patients must meet all the UAB diagnosis and disease status criteria for clinical appropriateness for myeloablative allo HSCT derived from ASBMT and NCCN guidelines.
- 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.
- Adequate organ function: All organ function testing should be done within 28 days of study registration.
- Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
Key exclusion criteria (11 listed)
- 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.
- HIV positive patients.
- Prior autologous or allogeneic transplantation for any disease.
- Scheduled to receive non-myeloablative or reduced intensity conditioning regimen.
- High Risk Features associated with increased relapse risk or poor outcomes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD3+ T cell depletionThe peripheral blood stem cell product is engineered to deliver a dose of 15 to 20 x10^7 CD3+ cells/kg recipient body weight. Other components of the graft will not be manipulated and the recipient will receive the total number of cells collected with the exception of minimal losses that occur during the process of CD3+ T cell isolation. Following collection, CD3+ T cells will be enumerated and a portion of the product containing 15 to 20 x10^7 CD 3+ cells/kg will be set aside. The remainder of the product will be depleted of CD3+ T cells. Following CD3+ T cell depletion, the CD3+ T cell depleted product will then be combined with the unmanipulated product to provide the specified levels of CD3+ T cells/kg recipient body-weight. The graft is infused into the patient on the same day as selected and within 24 hours of donor aphaeresis. | Device | CD3+ T-cell depletion |
Primary outcome
Incidence and severity of acute graft versus host disease (aGVHD) with the chosen fixed dose of CD3+ cells
Time frame: 1 year
6 secondary outcomes
Time to engraftment
Time frame: 60 days
State of chimerism over time
Time frame: 2 years
Immune reconstitution over time
Time frame: 2 years
Incidence, severity and organ involvement with chronic GVHD (cGVHD)
Time frame: 2 years
Overall survival
Time frame: 2 years
Disease free survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- BMTCT Program Web SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman Saad, MD principal investigator
University of Alabama in Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD3+ T cell depletion in people with Hematopoietic Stem Cell Transplantation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of acute graft versus host disease (aGVHD) with the chosen fixed dose of CD3+ cells (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.