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TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders

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ClinicalTrials.gov Identifier: NCT04088760
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Cell Transplantation Drug: TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) Phase 2

Detailed Description:
Acute graft versus host disease (GVHD) remains a significant cause of morbidity and mortality and is the biggest barrier to successful allogeneic hematopoietic cell transplantation (HSCT) outcomes. Improved methods of acute GVHD prevention are needed. TCRαβ+/CD19+ depletion of allogeneic hematopoietic stem cell products offers an opportunity to limit the risk of acute GVHD by removing TCRαβ+ T cells and CD19+ B cells which participate in acute GVHD initiation and perpetuation. The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders in Children and Adolescent/Young Adult Patients
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : September 2025

Arm Intervention/treatment
Experimental: TCRαβ+/CD19+ depleted HSCT Drug: TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)
The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold.




Primary Outcome Measures :
  1. Incidence of infusion-related reactions [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. Engraftment and Sustained Donor Chimerism [ Time Frame: 100 days and 1 year ]
  2. Incidence of acute GVHD [ Time Frame: 100 days ]
  3. Incidence of chronic GVHD [ Time Frame: 1 year ]
  4. GVHD-free survival [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic HSCT who lacks an HLA-genotypically matched related donor.

Exclusion Criteria:

  • Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening infection. Patients with a prior history of allogenic transplant without active GVHD or life-threatening infection can be considered.

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): NCT04088760


Contacts
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Contact: Kelly McIntosh 513-803-0460 kelly.mcintosh@cchmc.org
Contact: Celeste Dourson 513-636-7679 Celeste.Dourson@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kelly McIntosh    513-803-0460    Kelly.McIntosh@cchmc.org   
Contact: Celeste Dourson    513-636-7679    Celeste.Dourson@cchmc.org   
Principal Investigator: Parinda Mehta, MD         
Principal Investigator: Rebecca Marsh, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04088760     History of Changes
Other Study ID Numbers: 2018-8568
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
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