Trial · NCT00520130
Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System
NCT00520130, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System. Trials, record NCT00520130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00520130
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Unrelated Donor Stem Cell Transplantation for Patients With Cancers of the Blood and Immune System
- NCT number
- NCT00520130
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Myelodysplastic Syndrome, Hodgkin's Lymphoma, Non-Hodgkin's Disease, Acute Leukemia, Multiple Myeloma
- Interventions
- Rituximab, Cyclosporine, Allogenic stem cell transplant (ASCT), Conditioning Chemotherapy, TMS, FLAG, EPOCH-F, Alemtuzumab
- First posted
- 2007-08-23
- Last updated
- 2019-03-05
- Results first posted
- 2017-08-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD) | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 42 | 95% Confidence Interval 26 to 57 | percentage of participants | |
| Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD) | B - Cyclosporine (AC) Arm | 38 | 95% Confidence Interval 23 to 53 | percentage of participants | |
| Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | Moderate or Severe cGVHD | 50 | 95% Confidence Interval 32 to 65 | percentage of participants |
| Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | B - Cyclosporine (AC) Arm | Moderate or Severe cGVHD | 12 | 95% Confidence Interval 4 to 25 | percentage of participants |
| Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | Severe cGVHD | 28 | 95% Confidence Interval 14 to 43 | percentage of participants |
| Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | B - Cyclosporine (AC) Arm | Severe cGVHD | 5 | 95% Confidence Interval 1 to 15 | percentage of participants |
| Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 6 mo (TMS=28; AC= 28) | 24 | Full Range 2 to 65 | % of naive (CCR7+CD45RA+) CD4 Cells |
| Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | B - Cyclosporine (AC) Arm | 6 mo (TMS=28; AC= 28) | 1 | Full Range 0 to 22 | % of naive (CCR7+CD45RA+) CD4 Cells |
| Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 12 mo (TMS=25; AC= 21) | 22 | Full Range 5 to 48 | % of naive (CCR7+CD45RA+) CD4 Cells |
| Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | B - Cyclosporine (AC) Arm | 12 mo (TMS=25; AC= 21) | 7 | Full Range 0 to 42 | % of naive (CCR7+CD45RA+) CD4 Cells |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 44 | |
| Overall Study | STARTED | B - Cyclosporine (AC) Arm | 45 | |
| Overall Study | COMPLETED | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 39 | |
| Overall Study | COMPLETED | B - Cyclosporine (AC) Arm | 44 | |
| Overall Study | NOT COMPLETED | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 5 | |
| Overall Study | NOT COMPLETED | B - Cyclosporine (AC) Arm | 1 |
Source ClinicalTrials.gov
Adverse events710
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 28 | 44 | 75 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | B - Cyclosporine (AC) Arm | 17 | 45 | 45 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 26 | 44 | 73 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | B - Cyclosporine (AC) Arm | 23 | 45 | 50 |
| other | Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 0 | 44 | 0 |
| other | Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | B - Cyclosporine (AC) Arm | 1 | 45 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 1 | 44 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | B - Cyclosporine (AC) Arm | 1 | 45 | 1 |
| other | Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 1 | 44 | 1 |
| other | Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | B - Cyclosporine (AC) Arm | 1 | 45 | 1 |
1 to 10 of 710Source ClinicalTrials.gov
See all 710 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 8 | 44 |
| Total, all-cause mortality | B - Cyclosporine (AC) Arm | 19 | 45 |
| Total, other adverse events | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 43 | 44 |
| Total, other adverse events | B - Cyclosporine (AC) Arm | 42 | 45 |
| Total, serious adverse events | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 36 | 44 |
| Total, serious adverse events | B - Cyclosporine (AC) Arm | 41 | 45 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm vs B - Cyclosporine (AC) Arm: Toxicities | Trial comparisons |
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm vs B - Cyclosporine (C) Arm: Early Treatment Related Mortality | Trial comparisons |
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm vs B - Cyclosporine (AC) Arm: deaths from any cause | Trial comparisons |
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm vs B - Cyclosporine (AC) Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00520130
GET https://conductscience.org/api/trials/v1/NCT00520130/results?page=2