Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2025-02-05

Brief Summary

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This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent System to promote engraftment of haploidentical CD34+ selected cells combined with single unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.

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Detailed Description

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In this clinical protocol, the CliniMACS® CD34 Reagent System will be used for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-haploidentical, related donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution. The haploidentical donor will be mobilized by G-CSF and undergo one apheresis to collect CD34+ stem cells. The products will be cryopreserved until the time of transplantation. Recipients with hematologic disorders who require transplant will receive a standard conditioning regimen and will receive an allograft on day 0 containing donor CD34+ cells that have been positively selected and T-cell depleted following G-CSF mobilization combined with a single UCB unit.

Conditions

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Hematologic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a phase 1/phase 2 study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Miltenyi CliniMACS® CD34 Reagent System

The haploidentical donor will be mobilized by G-CSF and undergo one apheresis to collect CD34+ selected stem cell product after Miltenyi CliniMACS® CD34+ selection. The products will be cryopreserved until the time of transplantation.

Recipients will receive a standard conditioning regimen. After the conditioning regimen, the subjects will receive an allograft on day 0 containing donor CD34+ cells that have been positively selected and T-cell depleted following G-CSF mobilization combined with a single UCB unit. UCB unit will not be manipulated, and will be prepared and infused separately following standard of care procedure.

Group Type EXPERIMENTAL

Miltenyi CliniMACS® CD34 Reagent System

Intervention Type DEVICE

Miltenyi CliniMACS® CD34 Reagent System will be used to prepare CD34+ enriched/T-cell depleted cells from haploidentical mobilized peripheral blood.

Interventions

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Miltenyi CliniMACS® CD34 Reagent System

Miltenyi CliniMACS® CD34 Reagent System will be used to prepare CD34+ enriched/T-cell depleted cells from haploidentical mobilized peripheral blood.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ages 18-80 years inclusive
* Diagnosed with high risk hematologic disorders warranting stem cell transplant per institutional standard of care
* Lack HLA-identical related donor
* Availability of at least one HLA- haploidentical (i.e. =\> 5/10 and \<= 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells.
* Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body weight

Exclusion Criteria

* HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation
* Any patient not meeting institutional standard guidelines for transplant eligibility

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No