RECRUITING

A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant

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

Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.

Official Title

A Feasibility Study of Using the CiniMacs® Device for Alpha/Best T-Cell Depletion in Stem Cell Transplant Recipients

Quick Facts

Study Start:2019-12-19
Study Completion:2035-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04337515

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. * Male or female 0-30 years of age at time of transplant admission
  2. * Documentation of a disease requiring HCT
  3. * A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
  4. * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
  1. * Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  2. * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  3. * Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
  4. * Patient with an anticipated life expectancy of \<1 month
  5. * Patients with known hypersensitivity to murine (mouse) proteins or iron dextran

Contacts and Locations

Study Contact

Christopher C. Dvorak, MD
CONTACT
415-476-0554
christopher.dvorak@ucsf.edu

Principal Investigator

Christopher C Dvorak, MD
PRINCIPAL_INVESTIGATOR
Professor of Clinical Pediatrics

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Christopher Dvorak

  • Christopher C Dvorak, MD, PRINCIPAL_INVESTIGATOR, Professor of Clinical Pediatrics

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 Date2019-12-19
Study Completion Date2035-01-01

Study Record Updates

Study Start Date2019-12-19
Study Completion Date2035-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Graft Vs Host Disease
  • Graft-versus-host-disease