Trial · NCT01754389
Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant
NCT01754389, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2017-07-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant. Trials, record NCT01754389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01754389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant
- NCT number
- NCT01754389
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 138 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Graft Versus Host Disease
- Interventions
- Tacrolimus, Methotrexate, Bortezomib, Sirolimus
- First posted
- 2012-12-21
- Last updated
- 2017-07-18
- Results first posted
- 2017-07-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Incidence of Grade II-IV GVHD | 6 months | The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 180 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution. |
| Secondary | Percentage of Participants With Non-relapse Mortality | 1 year | Non-relapse mortality by 1 year after stem cell infusion. |
| Secondary | Percentage of Participants With Relapse | 1 year | Relapse relapse-cum-immunosuppression-free survival at 1 year after stem cell infusion |
| Secondary | Percentage of Participants With Progression-free and Overall Survival | 1 year | Progression-free and overall survival 1 year post stem cell infusion |
| Secondary | Percentage of Participants With Chronic Graft Versus Host Disease | 1 year | Rates of chronic GVHD 1 year after stem cell infusion |
Source ClinicalTrials.gov
Outcomes5
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 Incidence of Grade II-IV GVHD | 6 months | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Non-relapse Mortality | 1 year | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Relapse | 1 year | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Progression-free and Overall Survival | 1 year | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Chronic Graft Versus Host Disease | 1 year | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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 Incidence of Grade II-IV GVHD | Arm A (Standard of Care) | 33 | 95% Confidence Interval 20 to 47 | Percentage of participants | |
| Percentage of Participants With Incidence of Grade II-IV GVHD | Arm B (Experimental) | 31 | 95% Confidence Interval 18 to 45 | Percentage of participants | |
| Percentage of Participants With Incidence of Grade II-IV GVHD | Arm C (Experimental) | 21 | 95% Confidence Interval 11 to 34 | Percentage of participants | |
| Percentage of Participants With Non-relapse Mortality | Arm A (Standard of Care) | 11 | 95% Confidence Interval 4 to 23 | Percentage of participants | |
| Percentage of Participants With Non-relapse Mortality | Arm B (Experimental) | 15 | 95% Confidence Interval 6 to 28 | Percentage of participants | |
| Percentage of Participants With Non-relapse Mortality | Arm C (Experimental) | 6.5 | 95% Confidence Interval 1.7 to 16 | Percentage of participants | |
| Percentage of Participants With Relapse | Arm A (Standard of Care) | 24 | 95% Confidence Interval 13 to 38 | Percentage of participants | |
| Percentage of Participants With Relapse | Arm B (Experimental) | 28 | 95% Confidence Interval 15 to 42 | Percentage of participants | |
| Percentage of Participants With Relapse | Arm C (Experimental) | 36 | 95% Confidence Interval 23 to 50 | Percentage of participants | |
| Percentage of Participants With Progression-free and Overall Survival | Arm A (Standard of Care) | Progression free survival | 64 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Standard of Care) | 46 | |
| Overall Study | STARTED | Arm B (Experimental) | 45 | |
| Overall Study | STARTED | Arm C (Experimental) | 47 | |
| Overall Study | COMPLETED | Arm A (Standard of Care) | 46 | |
| Overall Study | COMPLETED | Arm B (Experimental) | 45 | |
| Overall Study | COMPLETED | Arm C (Experimental) | 47 | |
| Overall Study | NOT COMPLETED | Arm A (Standard of Care) | 0 | |
| Overall Study | NOT COMPLETED | Arm B (Experimental) | 0 | |
| Overall Study | NOT COMPLETED | Arm C (Experimental) | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Acute Kidney Injury | Renal and urinary disorders | Arm A (Standard of Care) | 0 | 46 | 0 |
| serious | Acute Kidney Injury | Renal and urinary disorders | Arm B (Experimental) | 1 | 45 | 1 |
| serious | Acute Kidney Injury | Renal and urinary disorders | Arm C (Experimental) | 0 | 47 | 0 |
| serious | Deep Vein Thrombosis | Vascular disorders | Arm A (Standard of Care) | 0 | 46 | 0 |
| serious | Deep Vein Thrombosis | Vascular disorders | Arm B (Experimental) | 1 | 45 | 1 |
| serious | Deep Vein Thrombosis | Vascular disorders | Arm C (Experimental) | 2 | 47 | 2 |
| serious | Treatment Related Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Arm A (Standard of Care) | 0 | 46 | 0 |
| serious | Treatment Related Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Arm B (Experimental) | 0 | 45 | 0 |
| serious | Treatment Related Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Arm C (Experimental) | 1 | 47 | 1 |
| serious | Malignant Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Arm A (Standard of Care) | 2 | 46 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Standard of Care) | ||
| Total, all-cause mortality | Arm B (Experimental) | ||
| Total, all-cause mortality | Arm C (Experimental) | ||
| Total, other adverse events | Arm A (Standard of Care) | 0 | 46 |
| Total, other adverse events | Arm B (Experimental) | 0 | 45 |
| Total, other adverse events | Arm C (Experimental) | 0 | 47 |
| Total, serious adverse events | Arm A (Standard of Care) | 5 | 46 |
| Total, serious adverse events | Arm B (Experimental) | 9 | 45 |
| Total, serious adverse events | Arm C (Experimental) | 10 | 47 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29326124 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01754389
GET https://conductscience.org/api/trials/v1/NCT01754389/events?page=2