Trial · NCT00520130
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD) | 6 months | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | 2 years post transplant | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | percentage of participants | NUMBER |
| PRIMARY | Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | Recipient recovery at 6, 12 and 24 months post transplant | A 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 Cells | MEDIAN |
| PRIMARY | Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells | Recipient recovery at 6, 12 and 24 months post transplant | A 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 Cells | MEDIAN |
| 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 | 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 index | MEDIAN |
| 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 | 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 index | MEDIAN |
| SECONDARY | Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD) | 6 months | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | percentage of participants | NUMBER |
| SECONDARY | Toxicities | 103 months and 22 days | participants | NUMBER | |
| SECONDARY | Days to Engraftment of Neutrophils | 2 years | One 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 engraftment | MEDIAN |
| SECONDARY | Days to Engraftment of Platelets | 2 years | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Days | MEDIAN |
| SECONDARY | Days to Engraftment of Lymphocytes | 2 years | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Days | MEDIAN |
| SECONDARY | Overall Survival | Patients 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. | Months | MEDIAN |
| SECONDARY | Early Treatment Related Mortality | Less than or equal to 28 days after transplantation | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Late Treatment Related Mortality | Greater than 28 days after transplantation | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | percentage of participants | NUMBER |
| SECONDARY | Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant | Day 0, 1 week and 2 weeks | Following the focus on chronic graft-versus host disease (GVHD) as a primary outcome measure in 2011, this measure was not assessed. | ||
| SECONDARY | Immune Reconstitution of Normal Killer (NK) Cells | 2 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/µl | MEDIAN |
| SECONDARY | Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations | 2 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/µl | MEDIAN |
| SECONDARY | Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations | 2 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/µl | MEDIAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT00520130/outcomes