Registered outcomes14

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

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Graft failure rate	42 days after blood stem cell (PB) transplantation	Graft failure defined as having had a primary or secondary graft failure by 42 days after blood stem cell (PB) transplantation. Primary graft failure is defined as failure to achieve an absolute neutrophil count (ANC) of \>500/ μL by 42 days after blood stem cell (PB) transplantation or a total donor chimerism of \>5%. Secondary graft failure is defined as cytopenias after initial engraftment (ANC \<500/μL) and a total donor cell chimerism decreasing to less than 5%.
Secondary	Event-free survival (EFS) Rate	Duration of study, up to 7 years	Event-free survival is defined as the time from treatment initiation to the occurrence of primary graft failure, death, Graft-versus-Host Disease (GVHD) Grade III-IV, whichever comes first. Patients without events will be censored at the time of last follow-up assessment.
Secondary	Time to engraftment of Neutrophils	Up to 7 years	Time to neutrophil engraftment is defined as the first of 3 measurements on consecutive days when the patient has an absolute neutrophil count of 500/μL after conditioning.
Secondary	Time to engraftment of Platelets	Up to 7 years	Time to platelet engraftment will be defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count \> 50,000/μL AND did not receive a platelet transfusion in the previous 7 days. The exception is the case in which a subject is given a platelet transfusion specifically to achieve a platelet threshold to allow an elective invasive procedure, such as a central catheter removal. Time from treatment initiation to successful donor cell engraftment defined as having achieved \> 50% total Peripheral Blood Mononuclear Cells (PMC) donor cell chimerism upon successful engraftment at day +30 or upon meeting ANC and Plt engraftment whatever occurs first.
Secondary	Incidence of Graft-versus-Host Disease (GVHD) of any grade	Up to 7 years	Incidence of acute and chronic GVHD of any grade as evaluated according to The Center for International Blood and Marrow Transplant Research (CIBMTR) and National Institutes of Health (NIH) criteria respectively.
Secondary	Incidence of other transplant related toxicities	12 Months Post Stem Cell Transplant	Incidence of other transplant related toxicities, including Veno-occlusive disease (VOD), Idiopathic pneumonia syndrome (IPS), Central nervous system (CNS) toxicity, or Posterior reversible encephalopathy syndrome (PRES).
Secondary	Incidence of significant transplant-related infections	12 Months Post Stem Cell Transplant	Significant infections will be recorded including but not limited to bacterial or fungal sepsis, cytomegalovirus (CMV) reactivation with/without clinical disease, adenovirus infection, Epstein-Barr virus (EBV) reactivation with or without post-transplant lymphoproliferative disorder (PTLD), other significant viral reactivations or community-acquired viral infections and invasive mold infections.
Secondary	Number of participants with donor chimerism >5%	100 days post-transplant and 1 year post transplant	Chimerism is a measure of the engraftment of donor cells within the recipient and is expressed as the percentage ratio between the number of donor cells and recipient cells. Chimerism will be determined by Short Tandem Repeat analysis.
Secondary	Percentage of Participants who Achieve Immune Reconstitution	12 Months Post Stem Cell Transplant	Peripheral blood quantitative assessment of CD3+, CD4+, CD8+, CD19+, and CD16+/56+ lymphocytes will be assessed by flow cytometry. In addition, quantitative immunoglobulins will be measured for IgA, IgM and IgG. These will be performed at Day +60 (±10 days) as well as at 1 year (+/- 2 weeks) and after long term follow up at the discretion of the investigator. Descriptive statistics will be used to describe the percentage of patients who are able to achieve reconstitution of important lymphocyte subsets and B cell function at the defined timepoint above.
Secondary	Follicle-stimulating hormone (FSH) titer	At study inclusion and at 1 year post-transplant	To assess the impact of the conditioning on fertility, FSH titers will be measured.
Secondary	Luteinizing hormone (LH) titer	At study inclusion and at 1 year post-transplant	To assess the impact of the conditioning on fertility, LH titers will be measured.
Secondary	Anti-Müllerian Hormone (AMH) titer	At study inclusion and at 1 year post-transplant	To assess the impact of the conditioning on fertility, AMH titers will be measured
Secondary	Testosterone titer	At study inclusion and at 1 year post-transplant	To assess the impact of the conditioning on fertility, testosterone titers will be measured.
Secondary	Sperm titer	At study inclusion and at 1 year post-transplant	To assess the impact of the conditioning on fertility, sperm titers will be measured.

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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