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Acute Lymphoblastic LeukemiaPhase 2NCT05800210

Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases

A Phase 2 study testing Miltenyi CliniMACS Prodigy ® system in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by University of Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic… Read more about this study

Who is it for?
Ages 6 months to 39 years
What is being tested?
Miltenyi CliniMACS Prodigy ® system
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
3 May 2024to May 2028
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 6 months to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible:
  • ALL
  • ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (≤15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (≥0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (≤44 chromosomes)) in first remission
  • ALL in second remission and beyond
  • AML
  • History of AML induction/reinduction Failure (≤15% blasts at time of registration)
Show all 33Show fewer
  • AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)
  • AML with persistent minimal residual disease (MRD) in CR1(≥0.01% on flow or persistent abnormal karyotype detected by cytogenetics)
  • AML CR2 or beyond
  • AML in refractory relapse but ≤15% bone marrow leukemia blasts
  • Therapy-related AML
  • Juvenile MyeloMonocytic Leukemia (JMML)
  • JMML in CR1 without CBL mutation
  • JMML with recurrence of disease with or without CBL mutation
  • JMML CR2 or beyond
  • Chronic Myeloid Leukemia (CML)
  • 1. CML in CR with regard to blast crisis
  • High Risk Myelodysplastic syndrome (MDS)
  • Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL)
  • HL or NHL with a history of induction failure
  • HL or NHL in PR1 or PR2
  • HL or NHL in CR2 or subsequent remission
  • Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included).
  • HLA-matched (5-6/6) sibling donor, matched (8-10/10) unrelated donor available for stem cell donation, haplo-identical related donor (at least one full haplotype must be matched).
  • Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients >16 years of age and Lansky scores for patients ≤16 years of age.
  • Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:
  • Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 60% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.
  • Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender
  • Cardiac: Shortening fraction of ≥ 27% by echocardiogram) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA).
  • Hepatic: SGOT (AST) or SGPT (ALT) < 5 x upper limit of normal (ULN) for age. Conjugated bilirubin < 2.5 mg/dL, unless attributable to Gilbert's Syndrome.
  • Written informed consent obtained from the subject or guardian and the subject agrees to comply with all the study-related procedures.
  • Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 8 weeks after the last dose of study drug to minimize the risk of pregnancy.
  • Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 8 weeks following the last dose of study drug.

Who cannot join

  • Patients with documented uncontrolled infection
  • Patients who have received allogeneic hematopoietic stem cell transplantation within 6 months, unless being done as a boost.
  • Patients with active ≥Grade 2 aGVHD.
  • Demonstrated lack of compliance with medical care.
  • Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 8 weeks after the last dose of study drug.
  • Females who are known to be pregnant or breastfeeding.
  • History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
  • Prisoners or subjects who are incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Beate Greer contact

352-294-8744

bgreer01@ufl.edu

United States1 site, 1 recruiting

  • University of Florida

    Gainesville, Florida, 32608

    Beate Greer, 352-294-8744, bgreer01@ufl.edu

    Recruiting

Other trials in United States

About this study

This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.

Being tested
Miltenyi CliniMACS Prodigy ® system
Keywords
hematologic malignancy, GVHD, stem cell transplantation, graft manipulation
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Juvenile, Myelodysplastic Syndromes, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Non-Hodgkin, Hodgkin Disease, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Miltenyi CliniMACS Prodigy ® systemDevice

    Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.

Study groups in NCT05800210
Study groupRoleWhat they receive
Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graftExperimentalNot described
Receives: Device: Miltenyi CliniMACS Prodigy ® system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute graft versus host disease (aGVHD) incidence

    Compare the incidence of grade II to IV aGVHD following allogeneic stem cell trasplantation utilizing α/β CD3+ T-cell and CD19+ B-cell depletion compared to historical controls by day +100

    Measured: 100 days

Secondary outcomes (7)

  1. Event-free survival

    Evaluate the event-free survival, which is defined as being alive and without evidence of disease relapse

    Measured: 2 years

  2. Overall survival

    Evaluate the overall survival

    Measured: 2 years

  3. Probability of hematopoietic engraftment

    Determine the probability of hematopoietic engraftment, as measured by the presence of donor chimerism >95% by day 100

    Measured: 100 days

  4. Cytomegalovirus (CMV) viremia incidence

    Determine the incidence of CMV viremia. Viremia is defined as >1000copies/mL present on at least 2 weekly tests or requiring therapy.

    Measured: 1 year

  5. Epstein-Barr virus (EBV) viremia incidence

    Determine the incidence of EBV viremia. Viremia is defined as >1000copies/mL present on at least 2 weekly tests or requiring therapy.

    Measured: 1 year

  6. Adenovirus viremia incidence

    Determine the incidence of adenovirus viremia. Viremia is defined as >1000copies/mL present on at least 2 weekly tests or requiring therapy.

    Measured: 1 year

  7. Post-transplant lymphoproliferative disorder (PTLD) incidence

    Determine the incidence of PTLD

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start3 May 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800210
Sponsor's protocol ID
UF-PED-004
Status last verified
Jun 2026
First submitted
23 Mar 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Miltenyi CliniMACS Prodigy ® system in people with Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia, run by University of Florida 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 33 inclusion and 8 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 4 Jun 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?

Contact Beate Greer (352-294-8744, bgreer01@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute graft versus host disease (aGVHD) incidence (time frame: 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800210.

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 4 Jun 2026.

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