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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

6 Months to 39 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Jordan Milner, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2027-05