Hematologic MalignanciesPhase 2NCT02600208
Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device
A Phase 2 study testing CliniMACs in people with Hematologic Malignancies, run by Julie-An M. Talano at 1 site in United States.
Trial summary
This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy… Read more about this study
- Who is it for?
- Ages Up to 23 years, women only
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- CliniMACs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2026
- Phase
- Phase 2
- 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 Up to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient:
- Age. Patient age < 23 years. Both genders and all races eligible.
- Disease eligibility
- Leukemias/lymphomas:
- Acute myeloid leukemia, primary or secondary
- Disease status: remission or <10% bone marrow blasts
Show all 16Show fewer
- Myelodysplasia
- Acute lymphoblastic leukemia
- Disease status: in hematologic remission
- Chronic myelogenous leukemia:
- Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase.
- Mixed lineage or biphenotypic acute leukemia
- Lymphoblastic lymphoma
- Disease status: remission
- Burkitt's lymphoma/leukemia:
- Disease status: in remission
Who cannot join
- Patient
- Patients who do not meet disease, organ or infectious criteria.
- No suitable donor
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: BT13BTθ51 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha Beta T Cell and B Cell Depletion For Patients With Hematologic Malignancies
This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.
Read the detailed description
The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.
- Conditions
- Hematologic Malignancies
- Being tested
- CliniMACs
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACsDevice
Also called Alpha/Beta T-Cell Depletion
Depletion of Alpha Beta T cells in the PBSC graft
| Study group | Role | What they receive |
|---|---|---|
| Single Experimental Arm | Experimental | Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device Receives: Device: CliniMACs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device.
Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days.
Measured: DAY 42
Secondary outcomes (3)
Assess the probability of one year leukemia free survival (LFS).
Leukemia relapse is defined as presence of malignant cells in the blood or other body site after initiation of conditioning in a patient previously in remission.
Measured: 1 year
Estimate the incidence and extent of acute and chronic graft vs. host disease.
Acute GVHD will be graded using the standard Glucksberg grading system.
Measured: 1 year
Assess the incidence treatment-related mortality (TRM).
TRM is defined as death from non-disease related causes in the 100 days from stem cell infusion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie-An M. Talano
- Sponsor type
- University, hospital or other
- Collaborators
- Miltenyi Biotec, Inc.
- Responsible party
- Sponsor-investigator, Julie-An M. Talano, Medical College of Wisconsin
- Investigators
- Julie-An Talano, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600208
- Sponsor's protocol ID
- BT13BTθ51
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2015
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BT13BTθ51 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha Beta T Cell and B Cell Depletion For Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02600208
- Acronym / sponsor ID
- BT13BTθ51
- Conditions
- Hematologic Malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Julie-An M. TalanoUniversity, hospital or other
- Collaborators
- Miltenyi Biotec, Inc.
- Study start
- Oct 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Nov 2015 (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.
This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.
Detailed description
The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Experimental Arm | Experimental | Device: CliniMACsAlpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device |
Who may qualify
- Ages
- Up to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Age. Patient age < 23 years. Both genders and all races eligible.
- Disease eligibility
- Acute myeloid leukemia, primary or secondary
- Disease status: remission or <10% bone marrow blasts
- Myelodysplasia
Key exclusion criteria (3 listed)
- Patient
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 |
|---|---|---|
| CliniMACsAlso: Alpha/Beta T-Cell DepletionDepletion of Alpha Beta T cells in the PBSC graft | Device | Single Experimental Arm |
Primary outcome
Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device.
Time frame: DAY 42
Engraftment will be defined using the standard CIBMTR definition of ANC >500 for the first of 3 consecutive days.
3 secondary outcomes
Assess the probability of one year leukemia free survival (LFS).
Time frame: 1 year
Estimate the incidence and extent of acute and chronic graft vs. host disease.
Time frame: 1 year
Assess the incidence treatment-related mortality (TRM).
Time frame: 1 year
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 1 May 2026.
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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.
Julie-An Talano, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CliniMACs in people with Hematologic Malignancies, run by Julie-An M. Talano 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 16 inclusion and 3 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 1 May 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device. (time frame: DAY 42). 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 1 May 2026.