Back to results

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

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:

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.

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

NCT ID

NCT04099966

First Posted

September 18, 2019

Last Updated

September 27, 2022

Sponsor

Mitchell Cairo

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

Data Monitoring Committee

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

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

mitchell_cairo@nymc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren Harrison, RN

Phone

6172857844

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

mitchell_cairo@nymc.edu

First Name & Middle Initial & Last Name & Degree

Lauren Harrison, MSN

Phone

6172857844

lauren_harrison@nymc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs