αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

Hematologic Malignancy Clinical Trial

— TB19DHCT  

Official title:

αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT) for Children and Young Adults With Hematologic Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082947
• Other study ID #: TB19DHCT
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: December 1, 2030

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: Clelie Peck
• Phone: 614-722-5634
• Email: clelie.peck[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT). Patients will receive an allogenic HSCT from a matched unrelated donor (MUD), mismatch unrelated donor (MMUD) or a mismatched related (haploidentical) donor. Patients will receive a granulocyte-colony stimulating factor (G-CSF) ± Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS® αβT cell/CD19+B cell depletion. Cluster of Differentiation 34 (CD34) and αβT cell content of the graft is determined based on the transplant indication.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

• Age = 30 years

• Patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor.

• Karnofsky Index or Lansky Performance Scale = 60 % on pre-transplant evaluation.

• Karnofsky scores must be used for patients > 16 years of age and Lansky scores for patients = 16 years of age.

• Patient or legal guardian must give informed consent if patient is = 18 years. Legal guardian must give informed consent (and patient must give assent if appropriate) if patient is < 18 years.

• Adequate organ function (within 4 weeks of initiation of preparative regimen). For patients receiving Myeloablative conditioning (MAC) on this platform, they should meet organ function to tolerate MAC. Similar if patients are receiving Reduced intensity conditioning (RIC).

• High resolution human leukocyte antigen (HLA) available

Exclusion Criteria:

• Patient does not have a suitable donor who is willing and able (meets donor criteria).

• Patient reports a history of allergic reactions to murine protein

• Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. Female patients of childbearing potential females =11 years of age or post- menarche and should have a negative pregnancy test

• Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation. Viremia by Pluripotency Check (PCR) analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic -

• Patients receiving umbilical cord blood and matched sibling donor transplants

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Hematopoietic Stem Cell Transplantation
• Neoplasms

Intervention

Device:
• CliniMACS®
CliniMACS® aßT cell/CD19+B cell depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year overall survival of patients undergoing allogeneic HSCT using the T-Cell Receptor (TCR) aß/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)	One-year overall survival of patients undergoing allogeneic HSCT	1 year
Secondary	Neutrophil and platelet engraftment following TCR aß/CD19+ depleted alternative donor (MUD, MMUD and haploidentical) HSCT	Neutrophil and platelet engraftment by day 100	100 days
Secondary	Incidence of final status graft failure	Incidence of final status graft failure by 1 year	1 year
Secondary	Incidence grade III-IV acute graft versus host disease (GVHD)	Incidence grade III-IV acute graft versus host disease (GVHD) by 1 year	1 year
Secondary	Incidence of chronic GVHD	Incidence of chronic GVHD by 1 year	1 year
Secondary	100 day and 1 year Transplant related mortality	100 day and 1 year Transplant related mortality by 1 year	1 year
Secondary	1 year Event free survival	1 year Event free survival	1 year