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Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05800210•University of Florida

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 39 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A. Children, Adolescents, Young adults (ages 6 months to ≤39 years) with the following diseases may be eligible:
•i. ALL
•1. 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
•2. ALL in second remission and beyond
•ii. AML
•1. History of AML induction/reinduction Failure (≤15% blasts at time of registration)
•2. AML in CR1 with poor cytogenetics (i.e., 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others)
•3. AML with persistent minimal residual disease (MRD) in CR1(≥0.01% on flow or persistent abnormal karyotype detected by cytogenetics)
•4. AML CR2 or beyond
•5. AML in refractory relapse but ≤15% bone marrow leukemia blasts
+23 more criteria

Exclusion Criteria

•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.

Locations (1)

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

May 3, 2024

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2027

Last Updated

June 15, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaJuvenile Myelomonocytic LeukemiaMyelodysplastic SyndromesChronic Myeloid LeukemiaLymphoma, Non-HodgkinLymphoma, Hodgkin

Interventions

Miltenyi CliniMACS Prodigy ® system

DEVICE

Contacts

Beate Greer

CONTACT

352-294-8744 bgreer01@ufl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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