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Outcome Measures

Primary Outcomes (5)

Measure rates of neutrophil and platelet engraftment
Patients undergoing partially matched related donor hematopoietic cell transplantation with an αβT cell / CD19+ B cell depleted graft should have an improved rate of engraftment.
4 years
Measure incidence of acute GVHD
Patients undergoing partially matched related donor hematopoietic cell transplantation with an αβT cell / CD19+ B cell depleted graft should have a lower incidence of acute and chronic GVHD.
4 years
Measure rates of immune reconstitution
Patients undergoing partially matched related donor hematopoietic cell transplantation with an αβT cell / CD19+ B cell depleted graft should have a improved rate of immune reconstitution.
4 years
Measure rates of platelet engraftment
Patients undergoing partially matched related donor hematopoietic cell transplantation with an αβT cell / CD19+ B cell depleted graft should have an improved rate of engraftment.
4 years
Measure incidence of chronic GVHD
Patients undergoing partially matched related donor hematopoietic cell transplantation with an αβT cell / CD19+ B cell depleted graft should have a lower incidence of acute GVHD.

Secondary Outcomes (4)

Measure overall survival
4 years
Define nonhematopoietic regimen related toxicities
4 years
Measure relapse rate
4 years
Measure disease free survival
4 years

Study Arms (1)

CliniMACS Isolation

EXPERIMENTAL

The mobilized peripheral blood cell collection (apheresis product) will be processed using a Miltenyi CliniMACS device according to the manufacturing instructions. The processing will deplete the αβTCR+ cells and CD19+ cells from the apheresis product to formulate the graft.

Device: CliniMACS® TCRαβ/CD19 Combined Depletion System

Interventions

CliniMACS® TCRαβ/CD19 Combined Depletion SystemDevice

CliniMACS Isolation

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Study Design

Study Type

interventional

Phase

phase 1 2

Allocation

Masking

NONE

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: The mobilized peripheral blood cell collection (apheresis product) will be processed using a Miltenyi CliniMACS device according to the manufacturing instructions. The processing will deplete the αβTCR+ cells and CD19+ cells from the apheresis product to formulate the graft.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia

Brief Summary

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First Posted

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Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (4)

Study Arms (1)

CliniMACS Isolation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

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Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (4)

Study Arms (1)

CliniMACS Isolation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations