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CD34+ (Non-Malignant) Stem Cell Selection for Patients Receiving Allogeneic Stem Cell Transplantation

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Jan 2022 to Feb 2030
    • Study completion date: Jan 2030 to Feb 2030
    v7
  3. Phase: Early Phase 1 to Phase 1/2v6 Show 6 more changesShow less
    • Lead sponsor: Diane George, MD to Diane George
    • Primary completion date: Dec 2019 to Jan 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 25 to confirmed 37
    • Study completion date: Dec 2019 to Jan 2030
    • Site details revised
  4. Study Status, Study Description, Arms and Interventionsv5
  5. Phase: Not applicable to Early Phase 1v4 Show 4 more changesShow less
    • Study description expanded, about 7 words
    • Site contact updated
    • Eligibility criteria expanded, about 4 words
    • Study title shortened, about 2 words
Show 2 earlier versionsHide 2 earlier versions
  1. Primary and study completion dates: Mar 2017 to Dec 2019
    • Eligibility criteria expanded, about 136 words
    v3
  2. Interventions: CliniMacs (PLUS) Reagent System (Biological) to CD34 Stem Cell Selection Therapy (Biological)
    • Eligibility criteria shortened, about 75 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study's goal is to determine the frequency and severity of acute graft versus host disease, to evaluate incidence of primary and secondary graft rejection, to assess event free survival and overall survival, to determine the time to neutrophil and platelet engraftment, to determine the time to immune reconstitution (including normalization of T, B and natural killer (NK) cell repertoire and Immunoglobulin G production), and to establish the incidence of infectious complications including bacterial, viral, fungal and atypical mycobacterial and other infections following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant disease.
Trial Details
NCT Number NCT01966367
Lead Sponsor Diane George
Conditions
(from sponsor)		 Bone Marrow Failure Syndrome, Severe Aplastic Anemia, Severe Congenital Neutropenia, Amegakaryocytic Thrombocytopenia, Diamond-Blackfan Anemia, Schwachman Diamond Syndrome, Primary Immunodeficiency Syndromes, Acquired Immunodeficiency Syndromes +8 more
Related terms Acquired Immunodeficiency Syndrome, Anemia, Aplastic, Anemia, Diamond-Blackfan, Anemia, Sickle Cell, Bone Marrow Failure Disorders, Hemoglobinopathies, Histiocytosis, Histiocytosis, Langerhans-Cell, Lymphohistiocytosis, Hemophagocytic, Macrophage Activation Syndrome, Neutropenia, Severe Congenital, Autosomal Recessive 3, Primary Immunodeficiency Diseases, Shwachman-Diamond Syndrome
Enrollment 37 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov