LeukemiaNCT05794880
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing
A study testing Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) in people with Leukemia and Acute Myeloid Leukemia in Remission, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on… Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Leukemia, Acute Myeloid Leukemia in Remission, Myelodysplasia
- What is being tested?
- Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to May 2032
- 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 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient age < 25 years. Both genders and all races eligible.
- Disease eligibility
- Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)
- Myelodysplasia
- Acute lymphoblastic leukemia - Disease status: MRD negative
- Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase
Show all 26Show fewer
- Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative
- Lymphoblastic lymphoma - Disease status: in remission
- Burkitt's lymphoma/leukemia - Disease status: in remission
- Lymphoma after relapse - Disease status: in remission
- Other malignant hematologic diseases in remission (to be approved by PI)
- Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
- Evaluation of organ status as per MCW BMT SOP
- Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
- Signed consent by parent/guardian or able to give consent if ≥18 years.
- Negative pregnancy test for patients capable of childbearing potential
- Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.
- Donor Eligibility:
- Unrelated donor meets National Marrow Donor Program criteria for donation
- Infectious disease testing
- MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.
- Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.
- Unrelated Donor:
- HLA typing of at least 10 alleles is required. Donor must be matched at 9/10 or 10/10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis
- Haploidentical Related Donor:
- Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5/10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8/10) encouraged.
Who cannot join
- Patients who do not meet disease, organ, or infectious criteria.
- No suitable donor
- Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.
- Participating in a concomitant Phase 1 or 2 study involving treatment of disease
- Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Meredith Beversdorf, RN, 414-266-5891, mbeversdorf@childrenswi.org
Amy Moskop
About this study
Official title: Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641
This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival
- Conditions
- Leukemia, Acute Myeloid Leukemia in Remission, Myelodysplasia, Acute Lymphoblastic Leukemia in Remission, Chronic Myelogenous Leukemia - Chronic Phase, Chronic Myelogenous Leukemia, Accelerated Phase
- Being tested
- Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)
- Medical subject headings
- Leukemia, Anemia, Refractory, with Excess of Blasts, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)Device
Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.
| Study group | Role | What they receive |
|---|---|---|
| Alpha/Beta T cell depletion (TCD) plus CD19+ depletion | Experimental | Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies Receives: Device: Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
Measured: 1 year
Secondary outcomes (6)
Evaluate incidence of chronic GVHD
Measured: 5 years
Evaluate time to platelet engraftment
Measured: 1 years
Assess incidence of viral infections
Measured: 2 years
Evaluate incidence of relapse/progressive disease
Measured: 2 years
Evaluate incidence of treatment-related mortality (TRM).
Measured: 2 years
Evaluate overall and relapse free survival (RFS) at 1 year
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 May 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Moskop, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794880
- Sponsor's protocol ID
- IIT-MOSKOP-MABD
- Status last verified
- May 2026
- First submitted
- 8 Mar 2023
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641
- ClinicalTrials.gov ID
- NCT05794880
- Acronym / sponsor ID
- IIT-MOSKOP-MABD
- Conditions
- Leukemia, Acute Myeloid Leukemia in Remission, Myelodysplasia, Acute Lymphoblastic Leukemia in Remission, Chronic Myelogenous Leukemia - Chronic Phase, Chronic Myelogenous Leukemia, Accelerated Phase
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 3 Apr 2023 (actual)
- 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 receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha/Beta T cell depletion (TCD) plus CD19+ depletion | Experimental | Device: Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (26 listed)
- Patient age < 25 years. Both genders and all races eligible.
- Disease eligibility
- Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)
- Evaluation of organ status as per MCW BMT SOP
- Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.
Key exclusion criteria (6 listed)
- Patients who do not meet disease, organ, or infectious criteria.
- No suitable donor
- Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants
- Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.
- Participating in a concomitant Phase 1 or 2 study involving treatment of disease
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 |
|---|---|---|
| Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion. | Device | Alpha/Beta T cell depletion (TCD) plus CD19+ depletion |
Primary outcome
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
Time frame: 1 year
6 secondary outcomes
Evaluate incidence of chronic GVHD
Time frame: 5 years
Evaluate time to platelet engraftment
Time frame: 1 years
Assess incidence of viral infections
Time frame: 2 years
Evaluate incidence of relapse/progressive disease
Time frame: 2 years
Evaluate incidence of treatment-related mortality (TRM).
Time frame: 2 years
Evaluate overall and relapse free survival (RFS) at 1 year
Time frame: 1 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 13 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi) in people with Leukemia and Acute Myeloid Leukemia in Remission, run by Medical College of Wisconsin 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 26 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 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.
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?
Contact Meredith Beversdorf, RN (414-266-5891, mbeversdorf@childrenswi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG (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 13 May 2026.