Trial · NCT02845596

Registered outcomes19

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

1 to 19 of 19

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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List	Outcome	Time frame	Description
Primary	Percentage of patients randomized to HSCT that actually complete HSCT	4 years	Feasibility of comparing outcomes of patients treated de novo with IST versus matched unrelated donor HSCT for pediatric acquired severe aplastic anemia as defined by percentage of patients randomized to HSCT that actually complete HSCT.
Secondary	Time from screening consent to randomization	4 years	To measure the time from screening consent and randomization of patients to initiation of the preparative regimen of those randomized to HSCT.
Secondary	Number of patients that fail to receive their primary assigned therapy (HSCT or IST).	4 years	Number of patients fail to receive their primary assigned therapy (HSCT or IST).
Secondary	Reasons why patients fail to receive their primary assigned therapy (HSCT or IST).	4 years	Reasons why patients fail to receive their primary assigned therapy (HSCT or IST).
Secondary	Treatment-related mortality at one year from randomization in both arms	1 Year	Number of deaths that are treatment related
Secondary	Overall Survival at one year from randomization in both arms	1 Year	percentage of enrolled patients living at 1 year post randomization
Secondary	Time from randomization to neutrophil recovery in both arms	4 years	Time from randomization to neutrophil recovery in both arms
Secondary	Time from randomization to platelet recovery in both arms	4 years	Time from randomization to platelet recovery in both arms
Secondary	Time from randomization to red blood cell recovery in both arms	4 years	Time from randomization to red blood cell recovery in both arms
Secondary	Time from randomization to cessation of immune suppression recovery in both arms	4 years	Time from randomization to cessation of immune suppression recovery in both arms
Secondary	Rates of primary and secondary graft rejection in the MUD HSCT arm	4 years	Rates of primary and secondary graft rejection in the MUD HSCT arm
Secondary	Rates of grade II-IV and III-IV acute GVHD, and extensive chronic GVHD in the MUD HSCT arm	4 years	Rates of grade II-IV and III-IV acute GVHD, and extensive chronic GVHD in the MUD HSCT arm
Secondary	Rates of IST response	4 years	Rates of IST response
Secondary	Rates of IST relapse	4 years	Rates of IST relapse
Secondary	Rates of secondary MDS or AML in both treatment arms.	4 years	Rates of secondary MDS or AML in both treatment arms.
Secondary	Rates of other secondary malignancies in both treatment arms.	4 years	Rates of other secondary malignancies in both treatment arms.
Secondary	Development of symptomatic PNH in both treatment arms.	4 years	Development of symptomatic PNH in both treatment arms.
Secondary	Incidence of significant infection in both treatment arms	4 years	Incidence of significant infection in both treatment arms
Secondary	Time to immune reconstitution in the HSCT arm	4 years	Time to immune reconstitution in the HSCT arm