Clinical Trials /

AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

NCT04099966

Description:

Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Hodgkin Lymphoma
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndromes
  • Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
  • Official Title: Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588

Clinical Trial IDs

  • ORG STUDY ID: NYMC 588
  • NCT ID: NCT04099966

Conditions

  • Acute Leukemia
  • Severe Aplastic Anemia
  • Non-hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Kostmann
  • Diamond Blackfan Anemia
  • Amegakaryocytic Thrombocytopenia
  • Sickle Cell Disease
  • Beta-Thalassemia

Interventions

DrugSynonymsArms
alpha beta depletionα/β CD3+/CD19+ cell depletionalpha beta cell depletion

Purpose

Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.

Detailed Description

      Patients wiith selected malignant or non-malignant conditions meeting eligibility criteria
      will be enrolled on this study. Patients will receive one of either full intensity, reduced
      intensity, or reduced toxicity conditioning appropriate based on disease, disease status,
      organ function and performance status and will undergo α/β T-cell and CD 19+ B cell depleted
      alloSCT.

      Patients will be following for engraftment, chimerism, immune reconstitution, GVHD and QOL.
    

Trial Arms

NameTypeDescriptionInterventions
alpha beta cell depletionExperimentalMatched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.
  • alpha beta depletion

Eligibility Criteria

        Inclusion Criteria:

          1. 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;

          2. 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

          3. High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin
             (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or
             subsequent remission

        5. Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte
        colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to
        corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell
        Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin
        SC Disease) 7. age 0-30 years 8. adequate organ function

        Exclusion Criteria:

          1. Females who are pregnant or breast-feeding are not eligible.

          2. Patients with documented uncontrolled infection at the time of study entry are not
             eligible.

          3. Karnofsky/Lansky (age appropriate) Performance Score <60

          4. Demonstrated lack of compliance with medical care

          5. Patients who have received allogeneic HSCT within 6 months, unless being done as a
             boost.

          6. Patients with active <Grade 2 GVHD.
      
Maximum Eligible Age:30 Years
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Time Frame:1 year
Safety Issue:
Description:patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells

Secondary Outcome Measures

Measure:incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
Time Frame:1 year
Safety Issue:
Description:patients will have routine chimerism performed to monitoring engraftment of donor cells
Measure:incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
Time Frame:1 year
Safety Issue:
Description:patients will be monitored post transplant for signs of acute and chronic GVHD

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Mitchell Cairo

Trial Keywords

  • allogeneic stem cell transplantation
  • t-cell depletion
  • alpha beta cell depletion

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