Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
1 other identifier
interventional
20
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
May 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedJune 15, 2025
June 1, 2025
2 years
March 23, 2023
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
100 days
Secondary Outcomes (7)
Event-free survival
2 years
Overall survival
2 years
Probability of hematopoietic engraftment
100 days
Cytomegalovirus (CMV) viremia incidence
1 year
Epstein-Barr virus (EBV) viremia incidence
1 year
- +2 more secondary outcomes
Study Arms (1)
Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graft
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- A. Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible:
- i. 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
- ii. AML
- History of AML induction/reinduction Failure (≤15% blasts at time of registration)
- 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
- iii. Juvenile MyeloMonocytic Leukemia (JMML)
- JMML in CR1 without CBL mutation
- JMML with recurrence of disease with or without CBL mutation
- JMML CR2 or beyond
- +18 more criteria
You may not qualify if:
- A. Patients with documented uncontrolled infection
- B. Patients who have received allogeneic hematopoietic stem cell transplantation within 6 months, unless being done as a boost.
- C. Patients with active ≥Grade 2 aGVHD.
- D. Demonstrated lack of compliance with medical care.
- E. 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.
- F. Females who are known to be pregnant or breastfeeding.
- G. 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.
- H. Prisoners or subjects who are incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Florida Department of Healthcollaborator
- Ocala Royal Dames for Cancer Researchcollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32608, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan Milner, MD
University of Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 5, 2023
Study Start
May 3, 2024
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
June 15, 2025
Record last verified: 2025-06