Registered outcomes18

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

1 to 18 of 18

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD)	6 months	Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.
Primary	Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD)	2 years post transplant	Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria.
Primary	Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells	Recipient recovery at 6, 12 and 24 months post transplant	The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry.
Primary	Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells	Recipient recovery at 6, 12 and 24 months post transplant	The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry.
Primary	Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire	Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant	Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.
Primary	Changes in CD8 T Cell Receptor Vbeta Repertoire	Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant	Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.
Secondary	Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD)	6 months	Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria.
Secondary	Toxicities	103 months and 22 days	Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Secondary	Days to Engraftment of Neutrophils	2 years	Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3).
Secondary	Days to Engraftment of Platelets	2 years	Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support
Secondary	Days to Engraftment of Lymphocytes	2 years	Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3).
Secondary	Overall Survival	Patients were followed for an average of up to 5 years.	Time between the first day of transplant to the day of death.
Secondary	Early Treatment Related Mortality	Less than or equal to 28 days after transplantation	Any death occurring within 28 days after transplantation in a patient in continuous remission.
Secondary	Percentage of Participants With Late Treatment Related Mortality	Greater than 28 days after transplantation	Any death occurring 28 days or more after transplantation in a patient in continuous remission.
Secondary	Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant	Day 0, 1 week and 2 weeks	During depletion of lymphocytes during transplant conditioning, levels of homeostatic cytokines increase in the blood. These then decline with the expansion of new donor-derived cells. The rapidity of decline may predict acute graft versus host disease (AGVHD). Decline in cytokine IL-7 will be assessed by the enzyme-linked immunosorbent assay (ELISA).
Secondary	Immune Reconstitution of Normal Killer (NK) Cells	2 weeks, and 1, 3, 6, 12, and 24 months post transplant	Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.
Secondary	Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations	2 weeks, and 1, 3, 6, 12 and 24 months post transplant	Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.
Secondary	Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations	2 weeks, 1, 3, 6, 12 and 24 months post transplant	Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count.

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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