RECRUITING

Immune Disorder HSCT Protocol

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

This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.

Official Title

A Study of Hematopoietic Stem Cell Transplantation (HSCT) in Immune Function Disorders Using a Reduced Intensity Preparatory Regime

Quick Facts

Study Start:2013-03
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01821781

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 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * \</= 28 years of age
  2. * Performance status \>/= 40
  3. * DLCO \>/= 40%
  4. * LVEF \>/=40% or LVSF \>/=26%
  5. * Serum creatinine \< 2x ULN
  6. * Liver enzymes \</= 5x ULN
  7. * Negative pregnancy test
  8. * Suitably matched donor (6/6 matched sib UCB, 8/8 matched sib BM or PBSC, 5-6/6 matched unrelated UCB, 7-8/8 matched unrelated BM, double cord)
  1. * Known diagnosis of HIV I/II
  2. * Pregnant or breastfeeding
  3. * Uncontrolled invasive fungal or bacterial infections within 1 month prior to starting alemtuzumab
  4. * Uncontrolled viral infection within 1 week prior to starting alemtuzumab

Contacts and Locations

Study Locations (Sites)

Washington University
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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 Date2013-03
Study Completion Date2027-03

Study Record Updates

Study Start Date2013-03
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Immune deficiency
  • Immune disorders
  • Immune dysregulatory
  • Reduced Intensity
  • Alemtuzumab
  • Campath

Additional Relevant MeSH Terms

  • Immune Deficiency Disorders
  • Severe Combined Immunodeficiency
  • Chronic Granulomatous Disease
  • X-linked Agammaglobulinemia
  • Wiskott-Aldrich Syndrome
  • Hyper-IgM
  • DiGeorge Syndrome
  • Chediak-Higashi Syndrome
  • Common Variable Immune Deficiency
  • Immune Dysregulatory Disorders
  • Hemophagocytic Lymphohistiocytosis
  • IPEX
  • Autoimmune Lymphoproliferative Syndrome
  • X-linked Lymphoproliferative Syndrome