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Trial · NCT07904234

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to Neutrophil EngraftmentUp to Day 30 post-transplant
Time from transplant infusion to the first day of absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L maintained for 3 consecutive days in recipients receiving PBSC products collected using a closed apheresis procedure without gas-phase air exposure.
SecondarypO₂ of PBSC Collection ProductImmediately after PBSC collectionpO₂ level in PBSC collection products collected using a closed apheresis procedure without gas-phase air exposure.
SecondaryROS Levels in CD34⁺ CellsDay 0 (at collection)ROS levels in CD34⁺ hematopoietic stem and progenitor cells (HSPCs) collected using a closed apheresis procedure without gas-phase air exposure.
SecondaryCD34⁺ HSPC ViabilityDay 0 (at collection)Percentage of viable CD34⁺ hematopoietic stem and progenitor cells (HSPCs) in PBSC products collected using a closed apheresis procedure without gas-phase air exposure.
SecondaryCFU Formation Capacity of CD34⁺ HSPCsDay 0 (at collection)Colony-forming unit (CFU) formation capacity of CD34⁺ hematopoietic stem and progenitor cells (HSPCs) in PBSC products collected using a closed apheresis procedure without gas-phase air exposure.
SecondaryCorrelation Between Collection Product pO₂ and Time to ANC EngraftmentUp to Day 100 post-transplantCorrelation coefficient between pO₂ level in PBSC collection products and time to absolute neutrophil count (ANC) engraftment in recipients after transplant.
SecondaryCorrelation Between Collection Product pO₂ and Time to PLT EngraftmentUp to Day 100 post-transplantCorrelation coefficient between pO₂ level in PBSC collection products and time to platelet (PLT) engraftment in recipients after transplant.
SecondaryTime to Platelet EngraftmentUp to Day 100 post-transplant
Time from transplant infusion to the first day of platelet count ≥ 20 × 10⁹/L maintained for 7 consecutive days without platelet transfusion in recipients receiving PBSC products collected by low-oxygen closed apheresis compared with standard apheresis.
SecondaryIncidence of Poor EngraftmentUp to Day 100 post-transplant
Proportion of recipients with poor graft function (PGF), defined as cytopenia in at least two cell lineages persisting beyond Day 28 post-transplant with full donor chimerism and absence of relapse or severe GVHD, in recipients receiving PBSC products collected by low-oxygen closed apheresis compared with standard apheresis.
SecondaryEarly Donor ChimerismUp to Day 100 post-transplantPercentage of donor-derived cells (donor chimerism) in recipients after transplant, assessed by flow cytometry.
SecondaryIncidence of Donor Adverse Events During and After PBSC CollectionFrom enrollment to Day 30 post-transplant
Incidence and severity of adverse events in donors during and after PBSC collection using a closed apheresis procedure without gas-phase air exposure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
SecondaryIncidence of Recipient Adverse Events After TransplantFrom transplant to Day 30 post-transplant
Incidence and severity of adverse events in recipients from transplant to Day 30 post-transplant after receiving PBSC products collected using a closed apheresis procedure without gas-phase air exposure, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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