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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099966
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Mitchell Cairo, New York Medical College

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Severe Aplastic Anemia Non-hodgkin Lymphoma Hodgkin Lymphoma Kostmann Diamond Blackfan Anemia Amegakaryocytic Thrombocytopenia Sickle Cell Disease Beta-Thalassemia Drug: alpha beta depletion Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Arms and Interventions
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Arm Intervention/treatment
Experimental: alpha beta cell depletion
Matched 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.
 Drug: alpha beta depletion
donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.
Other Name: α/β CD3+/CD19+ cell depletion


Outcome Measures
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Primary Outcome Measures :
  1. incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells [ Time Frame: 1 year ]
    patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells


Secondary Outcome Measures :
  1. incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion [ Time Frame: 1 year ]
    patients will have routine chimerism performed to monitoring engraftment of donor cells

  2. incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion [ Time Frame: 1 year ]
    patients will be monitored post transplant for signs of acute and chronic GVHD


Eligibility Criteria
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Ages Eligible for Study:   1 Day to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099966


Contacts
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Contact: Mitchell S Cairo, MD 9145942150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, RN 6172857844 lauren_harrison@nymc.edu

Locations
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United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell S Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Lauren Harrison, MSN    6172857844    lauren_harrison@nymc.edu   
Sponsors and Collaborators
Mitchell Cairo
Investigators
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Study Chair: Mitchell S Cairo New York Medical College
More Information
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Responsible Party: Mitchell Cairo, Co-Investgiator, New York Medical College
ClinicalTrials.gov Identifier: NCT04099966    
Other Study ID Numbers: NYMC 588
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mitchell Cairo, New York Medical College:
allogeneic stem cell transplantation
t-cell depletion
alpha beta cell depletion
Additional relevant MeSH terms:
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Lymphoma
Anemia
Anemia, Sickle Cell
Thrombocytopenia
Thalassemia
Anemia, Aplastic
Hematologic Diseases
beta-Thalassemia
Anemia, Diamond-Blackfan
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Blood Platelet Disorders
Bone Marrow Failure Disorders
Bone Marrow Diseases
Anemia, Hypoplastic, Congenital
Red-Cell Aplasia, Pure
Congenital Bone Marrow Failure Syndromes