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Trial · NCT01962415

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryPost-transplant treatment-related mortality (TRM)1 year post-transplantThe number of deaths related to the research intervention at day 100, 6 months, and 1 year post-transplant.
PrimaryNeurodevelopmental milestones1 year post-transplantEvaluation of the pace of attaining neurodevelopmental milestones after reduced-intensity conditioning as compared to myeloablative conditioning historical controls from the target population(s).
PrimaryImmune Reconstitution1 year post-transplantEvaluation of the pace of immune reconstitution.
PrimarySevere opportunistic infections1 year post-transplantEvaluation of the incidence of severe opportunistic infections.
PrimaryGVHD occurrence1 year post-transplantDescription of the incidence of acute graft versus host disease (GVHD) (II-IV) and chronic extensive GVHD.
SecondaryDonor cell engraftment6 months post-transplant
Determination of the feasibility of attaining robust donor cell engraftment (\>50% donor chimerism at 6 months) following reduced-intensity conditioning (RIC) regimens prior to HSCT in the target population(s).
SecondaryNormal enzyme level1 year post-transplantDetermination of the feasibility of attaining and sustaining normal enzyme levels in the target population(s).
SecondaryNeutrophil recovery1 year post-transplantDetermination of the pace of neutrophil recovery.
SecondaryPlatelet recovery1 year post-transplantDetermination of the pace of platelet recovery.
SecondaryGrade 3-4 organ toxicity1 year post-transplantThe number of grade 3-4 organ adverse events.
SecondaryLate graft failure1 year post-transplantEvaluation of the incidence of late graft failure.

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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