RECRUITING

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

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Juvenile Myelomonocytic Leukemia Myelodysplastic Syndromes Chronic Myeloid Leukemia Lymphoma, Non-Hodgkin Lymphoma, Hodgkin hematologic malignancy GVHD stem cell transplantation graft manipulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-03

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05800210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
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 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 6. Therapy-related AML 1. JMML in CR1 without CBL mutation 2. JMML with recurrence of disease with or without CBL mutation 3. JMML CR2 or beyond 1. CML in CR with regard to blast crisis 1. HL or NHL with a history of induction failure 2. HL or NHL in PR1 or PR2 3. HL or NHL in CR2 or subsequent remission	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

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
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
6. Therapy-related AML
1. JMML in CR1 without CBL mutation
2. JMML with recurrence of disease with or without CBL mutation
3. JMML CR2 or beyond
1. CML in CR with regard to blast crisis
1. HL or NHL with a history of induction failure
2. HL or NHL in PR1 or PR2
3. HL or NHL in CR2 or subsequent remission

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Priya Gurjar

CONTACT

352-273-6772

PMO@cancer.ufl.edu

Principal Investigator

Jordan Milner, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32608

United States

Collaborators and Investigators

Sponsor: University of Florida

Jordan Milner, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-05-03

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

hematologic malignancy
GVHD
stem cell transplantation
graft manipulation

Additional Relevant MeSH Terms

Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Juvenile Myelomonocytic Leukemia
Myelodysplastic Syndromes
Chronic Myeloid Leukemia
Lymphoma, Non-Hodgkin
Lymphoma, Hodgkin