RECRUITING

Expanded Access Protocol Using CD3+/CD19+ Depleted PBSC

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Conditions

LeukemiaInborn Errors of MetabolismBone Marrow Failure SyndromesImmunodeficienciesImmunodysregulation Polyendocrinopathy Enteropathy X-linked Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal 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 IRB approved protocols that utilize CliniMACs technology for T depletion.

Official Title

Expanded Access Protocol Using CD3+/CD19+ Depleted Unrelated Donor or Related Donor Peripheral Stem Cells

Quick Facts

Study Start:2013-12
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02356653

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients who lack a fully HLA matched sibling and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT) but are not deemed suitable candidates per their treating clinical team for current open institutional protocols using ClinMACs device for CD3+/CD19+ depletion.
  2. 2. Patients with the following transplantable diseases:
  3. 3. Signed informed consent
  4. 4. Lansky or Karnofsky performance ≥60
  5. 5. Hematologic and Organ Function per current institutional SOP.
  6. 6. Infectious Evaluation as per current institutional SOP.
  7. 7. Participants of childbearing potential must have a negative pregnancy test as per institutional SOP
  8. 8. In cases that are deemed clinical emergencies (primary or secondary graft failure, severe marrow suppression), the above status criteria will be waived.
  9. 9. Patients must have an identified living donor
  10. * Donor selection will comply with 21 CFR 1271
  11. * Unrelated donor that meets the matching criteria of the NMDP with allele matching at HLA -A, -B, -C, -DRB1, and -DQB1: Unrelated donors may be a 10/10 match, a 9/10 match, or an 8/10 match if one of the mismatches is at DQB1
  12. * Related donor suitable for mobilization infectious disease criteria as per SOP, including HIV, HepB, HepC PCR negative.
  13. * CHOP BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases. Our donor collection program is FACT accredited.
  14. * Unrelated donor identified through the National Marrow Donor Program (NMDP) and fulfills the NMDP criteria for donation. Unrelated donor willing and able to undergo mobilization of peripheral stem cells and apheresis.
  15. * The donors selected for this IND will either be unrelated donors identified through the National Marrow Donor Program (NMDP) or related donors. Regarding the unrelated donors; NMDP procedures for determining donor eligibility include donor screening and testing for relevant communicable disease agents and diseases
  1. 1. Uncontrolled bacterial, viral or fungal infections
  2. 2. Fully HLA matched sibling donor
  3. 3. Donor unable to donate peripheral stem cells
  4. 4. Pregnant participants

Contacts and Locations

Study Contact

Megan Atkinson
CONTACT
215-590-2820
cttsbmtintake@chop.edu
Patricia Hankins, BSN, RN, CCRC
CONTACT
215-590-5168
hankinsp@chop.edu

Principal Investigator

Timothy Olson, MD, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Timothy Olson, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-12
Study Completion Date2027-01

Study Record Updates

Study Start Date2013-12
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Leukemia
  • Inborn Errors of Metabolism
  • Bone Marrow Failure Syndromes
  • Immunodeficiencies
  • Immunodysregulation Polyendocrinopathy Enteropathy X-linked Syndrome