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

Primary Purpose

Acute Leukemia, Severe Aplastic Anemia, Non-hodgkin Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alpha beta depletion
Sponsored by
Mitchell Cairo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring allogeneic stem cell transplantation, t-cell depletion, alpha beta cell depletion

Eligibility Criteria

1 Day - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

alpha beta cell depletion

Arm Description

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.

Outcomes

Primary Outcome Measures

incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2019
Last Updated
September 27, 2022
Sponsor
Mitchell Cairo
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1. Study Identification

Unique Protocol Identification Number
NCT04099966
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mitchell Cairo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia, Severe Aplastic Anemia, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Kostmann, Diamond Blackfan Anemia, Amegakaryocytic Thrombocytopenia, Sickle Cell Disease, Beta-Thalassemia
Keywords
allogeneic stem cell transplantation, t-cell depletion, alpha beta cell depletion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
alpha beta cell depletion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
alpha beta depletion
Other Intervention Name(s)
α/β CD3+/CD19+ cell depletion
Intervention Description
donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.
Primary Outcome Measure Information:
Title
incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Description
patients will be monitored for any adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Time Frame
1 year
Secondary Outcome Measure Information:
Title
incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
Description
patients will have routine chimerism performed to monitoring engraftment of donor cells
Time Frame
1 year
Title
incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
Description
patients will be monitored post transplant for signs of acute and chronic GVHD
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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 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: Females who are pregnant or breast-feeding are not eligible. Patients with documented uncontrolled infection at the time of study entry are not eligible. Karnofsky/Lansky (age appropriate) Performance Score <60 Demonstrated lack of compliance with medical care Patients who have received allogeneic HSCT within 6 months, unless being done as a boost. Patients with active <Grade 2 GVHD.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell S Cairo, MD
Phone
9145942150
Email
mitchell_cairo@nymc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Harrison, RN
Phone
6172857844
Email
lauren_harrison@nymc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S Cairo
Organizational Affiliation
New York Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell S Cairo, MD
Phone
914-594-2150
Email
mitchell_cairo@nymc.edu
First Name & Middle Initial & Last Name & Degree
Lauren Harrison, MSN
Phone
6172857844
Email
lauren_harrison@nymc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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