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Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT

Study acronym: HSCT+RIC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Nov 2025 to Nov 2026
    • Study completion date: Nov 2026 to Nov 2027
    • Publications: details revised at 1 of 2 entries
    v23
  2. Site contact updatedv22
  3. Study description expanded, about 12 words
    • Site contact updated
    v21
  4. Primary completion date: Nov 2024 to Nov 2025
    • Study completion date: Nov 2024 to Nov 2026
    • Site contact updated
    • Publications: details revised at 1 of 2 entries
    v20
  5. Site contact updated
    • Publications: 1 to 2
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Re-verified, no change to tracked fieldsv18
  2. Primary and study completion dates: Nov 2022 to Nov 2024v17
  3. Secondary endpoints: 7 to 6v16
  4. Primary completion date: Nov 2021 to Nov 2022v15
  5. Re-verified, no change to tracked fieldsv14
  6. Primary completion date: Nov 2020 to Nov 2021v13 Show 4 more changesShow less
    • Study completion date: Nov 2021 to Nov 2022
    • Secondary endpoints: details revised at 6 of 7 entries
    • Study site revised
    • Eligibility criteria expanded, about 2 words
  7. Re-verified, no change to tracked fieldsv12
  8. Primary completion date: Nov 2019 to Nov 2020
    • Study completion date: Nov 2020 to Nov 2021
    • Site contact updated
    v11
  9. Enrollment target: 30 to 100v10
  10. Re-verified, no change to tracked fieldsv9
  11. Lead sponsor: University of Pittsburgh to Paul Szabolcsv8 Show 4 more changesShow less
    • Primary completion date: Nov 2018 to Nov 2019
    • Start date: Jun 26, 2012 to Feb 4, 2014
    • Study completion date: Nov 2019 to Nov 2020
    • Site contact updated
  12. Start date: Dec 2013 to Jun 26, 2012v7 Show 6 more changesShow less
    • Eligibility criteria shortened, about 119 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description shortened, about 76 words
    • Site contact updated
    • Study arms: 3 to 2
    • Study title shortened, about 4 words
  13. Study completion date: Nov 2019
    • Site contact updated
    v6
  14. Re-verified, no change to tracked fieldsv5
  15. Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description expanded, about 60 words
    • Study title expanded, about 1 word
    v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  17. Study description shortened, about 2 words
    • Study title expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) in patients with non-malignant disorders that are amenable to treatment with hematopoietic stem cell transplant (HSCT). After transplant, subjects will be followed for late effects and for ongoing graft success.
Trial Details
NCT Number NCT01962415
Lead Sponsor Paul Szabolcs
Conditions
(from sponsor)		 Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias, Inflammatory Conditions, Systemic Juvenile Idiopathic Arthritis (sJIA), Juvenile Rheumatoid Arthritis (JRA)
Related terms Adrenoleukodystrophy, alpha-Mannosidosis, Anemia, Diamond-Blackfan, Anemia, Sickle Cell, Arthritis, Juvenile, Autoimmune Lymphoproliferative Syndrome, beta-Thalassemia, Chediak-Higashi Syndrome, Congenital amegakaryocytic thrombocytopenia, Congenital Bone Marrow Failure Syndromes, Crohn Disease, Dyskeratosis Congenita, Gaucher Disease, Granulomatous Disease, Chronic, Hereditary Diffuse Leukoencephalopathy with Spheroids, Immune Dysregulation, Polyendocrinopathy, Enteropathy, X-Linked Syndrome, Inflammatory Bowel Diseases, Leukocyte adhesion deficiency type 1, Leukodystrophy, Globoid Cell, Leukodystrophy, Metachromatic, Lymphohistiocytosis, Hemophagocytic, Mucopolysaccharidoses, Mucopolysaccharidosis I, Mucopolysaccharidosis II, Osteopetrosis, Primary Immunodeficiency Diseases, Severe Combined Immunodeficiency, Sudden Infant Death, Syndrome, Wiskott-Aldrich Syndrome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov