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Trial · NCT00520130

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD)6 months2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.percentage of participantsNUMBER
PRIMARYPercentage of Participants With Chronic Graft Versus Host Disease (cGVHD)2 years post transplant2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.percentage of participantsNUMBER
PRIMARYRecovery of Naïve Cluster of Differentiation 4 (CD4) T CellsRecipient recovery at 6, 12 and 24 months post transplantA few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.% of naive (CCR7+CD45RA+) CD4 CellsMEDIAN
PRIMARYRecovery of Naïve Cluster of Differentiation 8 (CD8) T CellsRecipient recovery at 6, 12 and 24 months post transplantA few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study.% of naive (CCR7+CD45RA+) CD8 CellsMEDIAN
PRIMARYChanges in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta RepertoireDonor at time of collection and recipient at 1, 3, 6 and 12 months post transplant
The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.
Divergence indexMEDIAN
PRIMARYChanges in CD8 T Cell Receptor Vbeta RepertoireDonor at time of collection and recipient at 1, 3, 6 and 12 months post transplant
The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.
Divergence indexMEDIAN
SECONDARYPercentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD)6 months2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.percentage of participantsNUMBER
SECONDARYToxicities103 months and 22 daysparticipantsNUMBER
SECONDARYDays to Engraftment of Neutrophils2 yearsOne myeloma patient had graft failure in the AC Arm. 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.Days to neutrophil engraftmentMEDIAN
SECONDARYDays to Engraftment of Platelets2 years2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.DaysMEDIAN
SECONDARYDays to Engraftment of Lymphocytes2 years2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.DaysMEDIAN
SECONDARYOverall SurvivalPatients were followed for an average of up to 5 years.2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.MonthsMEDIAN
SECONDARYEarly Treatment Related MortalityLess than or equal to 28 days after transplantation2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.participantsNUMBER
SECONDARYPercentage of Participants With Late Treatment Related MortalityGreater than 28 days after transplantation2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included.percentage of participantsNUMBER
SECONDARYDecline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-TransplantDay 0, 1 week and 2 weeksFollowing the focus on chronic graft-versus host disease (GVHD) as a primary outcome measure in 2011, this measure was not assessed.
SECONDARYImmune Reconstitution of Normal Killer (NK) Cells2 weeks, and 1, 3, 6, 12, and 24 months post transplant
2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.
Cells/µlMEDIAN
SECONDARYImmune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations2 weeks, and 1, 3, 6, 12 and 24 months post transplant
2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.
Cells/µlMEDIAN
SECONDARYImmune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations2 weeks, 1, 3, 6, 12 and 24 months post transplant
2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated.
Cells/µlMEDIAN

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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