Trial · NCT01106833
Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
NCT01106833, Phase 2, Phase 3, Completed, Medical College of Wisconsin; results first posted 2018-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801). Trials, record NCT01106833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01106833
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
- NCT number
- NCT01106833
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 151 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Chronic GVHD
- Interventions
- Sirolimus + calcineurin inhibitor + prednisone, Sirolimus + prednisone
- First posted
- 2010-04-20
- Last updated
- 2018-12-05
- Results first posted
- 2018-08-14
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Treatment Success | 6 months and 24 months post-randomization | Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. |
| Secondary | Percentage of Participants With Overall Survival | 6 months and 24 months post-randomization | Overall survival is defined as survival of death from any cause. |
| Secondary | Percentage of Participants With Progression-free Survival | 6 months and 24 months post-randomization | Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint. |
| Secondary | Percentage of Participants With Failure-free Survival | 6 months and 24 months post-randomization | Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint. |
| Secondary | Percentage of Participants With Relapse | 6 months and 24 months post-randomization | Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint. |
| Secondary | Percentage of Participants With Secondary Immunosuppressive Therapy Initiated | 6 months and 24 months post-randomization | The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint. |
| Secondary | Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years | 2 years post-randomization | The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint. |
| Secondary | Prednisone Dose | Baseline, 6 months, and 1 year post-randomization | Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization. |
| Secondary | Change in Prednisone Dose From Baseline | 6 months and 1 year post-randomization | Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization. |
| Secondary | Serum Creatinine Level | Baseline, 6 months, and 1 year post-randomization | Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With Treatment Success | 6 months and 24 months post-randomization | Twelve participants withdrew study consent between 6 and 24 months post-randomization, so are excluded from the analysis of treatment success at 24 months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Overall Survival | 6 months and 24 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Progression-free Survival | 6 months and 24 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Failure-free Survival | 6 months and 24 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Relapse | 6 months and 24 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Secondary Immunosuppressive Therapy Initiated | 6 months and 24 months post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years | 2 years post-randomization | percentage of participants | NUMBER | |
| SECONDARY | Prednisone Dose | Baseline, 6 months, and 1 year post-randomization | Outcomes are analyzed in participants that were alive and completed assessments. | mg/kg/day | MEDIAN |
| SECONDARY | Change in Prednisone Dose From Baseline | 6 months and 1 year post-randomization | Outcomes are analyzed in participants that were alive and completed assessments. | mg/kg/day | MEDIAN |
| SECONDARY | Serum Creatinine Level | Baseline, 6 months, and 1 year post-randomization | Outcomes are analyzed in participants that were alive and completed assessments. | mg/dL | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group248
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Treatment Success | Sirolimus, Calcineurin Inhibitor, and Prednisone | Phase II: 6 Months / Yes | 33 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus and Prednisone | Phase II: 6 Months / Yes | 35 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus, Calcineurin Inhibitor, and Prednisone | Phase II: 6 Months / No | 33 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus and Prednisone | Phase II: 6 Months / No | 37 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus, Calcineurin Inhibitor, and Prednisone | Phase III: 24 Months / Yes | 9 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus and Prednisone | Phase III: 24 Months / Yes | 10 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus, Calcineurin Inhibitor, and Prednisone | Phase III: 24 Months / No | 49 | Participants | |
| Proportion of Participants With Treatment Success | Sirolimus and Prednisone | Phase III: 24 Months / No | 58 | Participants | |
| Percentage of Participants With Overall Survival | Sirolimus, Calcineurin Inhibitor, and Prednisone | 6 Months | 85.5 | 95% Confidence Interval 74.0 to 92.2 | percentage of participants |
| Percentage of Participants With Overall Survival | Sirolimus and Prednisone | 6 Months | 91.7 | 95% Confidence Interval 82.4 to 96.2 | percentage of participants |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sirolimus, Calcineurin Inhibitor, and Prednisone | 74 | |
| Overall Study | STARTED | Sirolimus and Prednisone | 77 | |
| Overall Study | COMPLETED | Sirolimus, Calcineurin Inhibitor, and Prednisone | 74 | |
| Overall Study | COMPLETED | Sirolimus and Prednisone | 77 | |
| Overall Study | NOT COMPLETED | Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 | |
| Overall Study | NOT COMPLETED | Sirolimus and Prednisone | 0 |
Source ClinicalTrials.gov
Adverse events38
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 |
|---|---|---|---|---|---|---|
| serious | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Sirolimus, Calcineurin Inhibitor, and Prednisone | 1 | 66 | 1 |
| serious | Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | Sirolimus and Prednisone | 0 | 72 | 0 |
| serious | Bradycardia | Cardiac disorders | Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 | 66 | 0 |
| serious | Bradycardia | Cardiac disorders | Sirolimus and Prednisone | 1 | 72 | 1 |
| serious | Cardiac fibrillation | Cardiac disorders | Sirolimus, Calcineurin Inhibitor, and Prednisone | 1 | 66 | 1 |
| serious | Cardiac fibrillation | Cardiac disorders | Sirolimus and Prednisone | 0 | 72 | 0 |
| serious | Coronary artery disease | Cardiac disorders | Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 | 66 | 0 |
| serious | Coronary artery disease | Cardiac disorders | Sirolimus and Prednisone | 1 | 72 | 1 |
| serious | Myocardial infarction | Cardiac disorders | Sirolimus, Calcineurin Inhibitor, and Prednisone | 1 | 66 | 1 |
| serious | Myocardial infarction | Cardiac disorders | Sirolimus and Prednisone | 1 | 72 | 1 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sirolimus, Calcineurin Inhibitor, and Prednisone | 16 | 66 |
| Total, all-cause mortality | Sirolimus and Prednisone | 13 | 72 |
| Total, other adverse events | Sirolimus, Calcineurin Inhibitor, and Prednisone | 0 | 66 |
| Total, other adverse events | Sirolimus and Prednisone | 0 | 72 |
| Total, serious adverse events | Sirolimus, Calcineurin Inhibitor, and Prednisone | 13 | 66 |
| Total, serious adverse events | Sirolimus and Prednisone | 12 | 72 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24CA076518 | A Data Resource for Blood and Marrow Transplants and Adoptive Cellular Therapy Research | SHAW, BRONWEN; MOSKOP, AMY M | MEDICAL COLLEGE OF WISCONSIN | NATIONAL CANCER INSTITUTE | 1998 to 2025 | NIH RePORTER |
| U01HL069294 | BMT Clinical Research Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sirolimus, Calcineurin Inhibitor, and Prednisone vs Sirolimus and Prednisone: deaths from any cause | Trial comparisons |
| Sirolimus, Calcineurin Inhibitor, and Prednisone vs Sirolimus and Prednisone: 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/NCT01106833
GET https://conductscience.org/api/trials/v1/NCT01106833/results?page=2