NCT03145545

Brief Summary

The primary objective of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

First QC Date

May 5, 2017

Last Update Submit

May 18, 2025

Conditions

LeukemiaBone Marrow Failure SyndromeImmunodeficiencies

Interventions

Apha/beta T and CD19+ cell depletion using CliniMACS deviceDEVICE

Stem cells will be processed using the CliniMACS device for alpha/beta and CD19+ T cell depletion. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique.

Eligibility Criteria

Age1 Month+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Uncontrolled bacterial, viral, or fungal infections
  • Fully HLA matched sibling donor (fully matched related donors including siblings may be included in special circumstances)
  • Donor unable to donate peripheral stem cells
  • Pregnant Females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

AVAILABLE

MeSH Terms

Conditions

LeukemiaBone Marrow Failure DisordersImmunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesImmune System Diseases

Study Officials

  • Tim Olson, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Atkinson

CONTACT

215-590-2820cttsbmtintake@chop.edu

Patricia Hankins, BSN, RN, CCRC

CONTACT

215-590-5168hankinsp@chop.edu

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Hematopoietic Stem Cell Transplantation (HSCT) Program

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 9, 2017

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations

US(1)