ACTIVE_NOT_RECRUITING

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

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Conditions

SCIDOmenn's SyndromeReticular DysgenesisWiskott-Aldrich SyndromeBare Lymphocyte SyndromeCommon Variable ImmunodeficiencyChronic Granulomatous DiseaseCD40 Ligand DeficiencyHyper IgM SyndromeX-linked Lymphoproliferative DiseaseHemophagocytic LymphohistiocytosisGriscelli SyndromeChediak-Higashi SyndromeLangerhan's Cell Histiocytosisimmunodeficiency disorderhistiocytic disorder

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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

This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.

Official Title

Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

Quick Facts

Study Start:2012-09-04
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT01652092

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 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of immunodeficiency or histiocytic disorder including the following:
  2. * Severe combined immunodeficiency (SCID - all variants)
  3. * Second bone marrow transplant (BMT) for SCID (after graft rejection)
  4. * Omenn's Syndrome
  5. * Reticular dysgenesis
  6. * Wiskott-Aldrich syndrome
  7. * Major histocompatibility complex (MHC) Class II deficiency (bare lymphocyte syndrome)
  8. * Hyper IgM Syndrome (CD40 Ligand Deficiency)
  9. * Common variable immunodeficiency (CVID) with severe phenotype
  10. * Chronic Granulomatous Disease (CGD)
  11. * Other severe Combined Immune Deficiencies (CID)
  12. * Hemophagocytic Lymphohistiocytosis (HLH)
  13. * X-linked Lymphoproliferative Disease (XLP)
  14. * Chediak-Higashi Syndrome (CHS)
  15. * Griscelli Syndrome
  16. * Langerhans Cell Histiocytosis (LCH)
  17. * Acceptable stem cell sources include:
  18. * HLA identical or 1 antigen matched sibling donor eligible to donate bone marrow
  19. * HLA identical or up to a 1 antigen mismatched unrelated BM donor
  20. * Sibling donor cord blood with acceptable HLA match and cell dose as per current institutional standards
  21. * Single unrelated umbilical cord blood unit with 0-2 antigen mismatch and minimum cell dose of \>5 x 10\^7 nucleated cells/kg as per current institutional guidelines
  22. * Double unrelated umbilical cord blood units that are:
  23. * up to 2 antigen mismatched to the patient
  24. * up to 2 antigen mismatched to each other
  25. * minimum cell dose of at least one single unit must be ≥ 3.5 x 10\^7 nucleated cells/kg
  26. * combined dose of both units must provide a total cell dose of ≥ 5 x 10\^7 nucleated cells/kg
  27. * Age: 0 to 50 years
  28. * Adequate organ function and performance status.
  29. * pregnant or breastfeeding
  30. * active, uncontrolled infection and/or HIV positive
  31. * acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Christen Ebens, MD
PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota

Study Locations (Sites)

Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

  • Christen Ebens, MD, PRINCIPAL_INVESTIGATOR, Masonic Cancer Center, University of Minnesota

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 Date2012-09-04
Study Completion Date2026-12

Study Record Updates

Study Start Date2012-09-04
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • immunodeficiency disorder
  • histiocytic disorder

Additional Relevant MeSH Terms

  • SCID
  • Omenn's Syndrome
  • Reticular Dysgenesis
  • Wiskott-Aldrich Syndrome
  • Bare Lymphocyte Syndrome
  • Common Variable Immunodeficiency
  • Chronic Granulomatous Disease
  • CD40 Ligand Deficiency
  • Hyper IgM Syndrome
  • X-linked Lymphoproliferative Disease
  • Hemophagocytic Lymphohistiocytosis
  • Griscelli Syndrome
  • Chediak-Higashi Syndrome
  • Langerhan's Cell Histiocytosis