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Alpha/beta T cell and CD19+ B cell depletion in Allogeneic Stem Cell Transplantation

  • Status
    Accepting Candidates
  • Age
    6 Months - 39 Years
  • Sexes
    All
  • Healthy Volunteers
    No

Objective

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.

Details

Full study title Alpha/beta T cell and CD19+ B cell depletion in Allogeneic Stem Cell Transplantation in Patients with Malignant Diseases
Protocol number OCR43112
ClinicalTrials.gov ID NCT05800210
Phase Phase 2

Eligibility

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

  6. Therapy-related AML

iii. Juvenile MyeloMonocytic Leukemia (JMML)

  1. JMML in CR1 without CBL mutation

  2. JMML with recurrence of disease with or without CBL mutation

  3. JMML CR2 or beyond

iv. Chronic Myeloid Leukemia (CML)

  1. CML in CR with regard to blast crisis

v. High Risk Myelodysplastic syndrome (MDS)

vi. Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL)

  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 B. 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). C. 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). D. 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. E. Adequate organ function (within 4 weeks of initiation of preparative regimen), defined

As:

i. 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.

ii. Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender

iii. Cardiac: Shortening fraction of ≥ 27% by echocardiogram) or ejection fraction of ≥ 50% by echocardiogram or radionuclide scan (MUGA).

iv. 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. F. Written informed consent obtained from the subject or guardian and the subject agrees to comply with all the study-related procedures. G. 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. H. 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.

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.

Lead researcher

  • Pediatric Hematologist/Oncologist (Child Cancer Specialist)

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.