Registered outcomes15

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

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List	Outcome	Time frame	Description
Primary	GVHD-free relapse-free Survival	1 year	Composite endpoint of 1-year GVHD-free, event free survival (GEFS) with the addition of vorinostat to standard serotherapy-free GVHD prophylaxis. Grade III-IV acute GVHD and chronic GVHD requiring immunosuppression will be considered in this assessment. Events contributing to this endpoint will include death due to any cause, primary or secondary graft failure/rejection, or second HSCT, whichever occurs first.
Primary	Primary graft failure/rejection	By day+42 post-Hematopoietic stem cell transplant	Defined as never achieving an absolute neutrophil count (ANC) ≥500/microliters (µL) or never achieving ≥5% donor myeloid chimerism assessed by peripheral blood chimerism assays by day +42 post-Hematopoietic stem cell transplant (HSCT). Second infusion of hematopoietic stem cells is also considered indicative of primary graft failure by day +42 post-HSCT.
Primary	Secondary graft failure/rejection	Beyond day +42 post-HSCT	Defined as \<5% donor myeloid chimerism in peripheral blood beyond day +42 post-HSCT in patients with prior documentation of hematopoietic recovery with ≥5% donor cells by day +42 post-HSCT.
Primary	Secondary graft failure/rejection	By day +42 post-HSCT	Second infusion of hematopoietic stem cells is also considered indicative of primary graft failure by day +42 post-HSCT
Secondary	Overall survival (OS) at day 100, 6-months, and 1-year post-HSCT	Day 100, 6-months, and 1-year post-HSCT	This will be measured after HSCT.
Secondary	Event Free Survival (EFS) at 1-year post-HSCT	1 year post-HSCT	An event will be defined as death due to any cause, graft rejection/failure, or second transplant, whichever occurs first.
Secondary	Neutrophil engraftment at day 42	Day 42 post-HSCT	The time to engraftment of neutrophils \>500/microliter (μl) was defined as per Center for International Blood and Marrow Transplant Research (CIBMTR) standards, requiring donor chimerism for neutrophil engraftment.
Secondary	Platelet engraftment at day 100 post-HSCT	Day 100 post-HSCT	Platelet engraftment is defined as independence from platelet transfusion for at least 3 days with a platelet count of more than ≥20 × 10\^9/L.
Secondary	Donor chimerism at day 28, 100, and 1-year post-HSCT	Day 28, 100, and 1-year post-HSCT	Number of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells.
Secondary	Primary graft failure at day 42	Day 42 post-HSCT
Secondary	Secondary graft failure post-HSCT	Day 42 post-HSCT
Secondary	Day 100 grade II-IV and grade III-IV GVHD	Day 100 post-HSCT
Secondary	Chronic GVHD requiring immunosuppressive therapy (IST) at 1-year post-HSCT	1-year post-HSCT
Secondary	Incidence of grade 4 systemic infections (septicemia) at 1-year post-HSCT	1-year post-HSCT
Secondary	Incidence of viral reactivation by 1-year post-HSCT	1 year post-HSCT

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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