Trial · NCT01445821
Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial
NCT01445821, Phase 3, Terminated, Northwestern University; results first posted 2020-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial. Trials, record NCT01445821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01445821
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial
- NCT number
- NCT01445821
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Scleroderma, Systemic
- Interventions
- Peripheral Blood Stem Cells, Cyclophosphamide, Mesna, rATG, Methylprednisolone, Filgrastim, Fludarabine
- First posted
- 2011-10-04
- Last updated
- 2020-07-23
- Results first posted
- 2020-07-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Failure | up to and post 12 months of treatment | Treatment failure will not occur until a minimum of 12 months after treatment at which time failure is defined as: 1. Increase of skin score (if \> 14 on enrollment) by \> 25% above enrollment value and must be documented on 2 occasions at least 6 months apart 2. Deterioration in percent predicted FVC by 10% below enrollment level, due to systemic sclerosis, and documented on 2 occasion at least 6 months apart |
| Secondary | Survival of Treatment | up to 12 months post treatment | Survival of Hematopoietic Stem Cell Transplant. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Failure | up to and post 12 months of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Survival of Treatment | up to 12 months post treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Failure | Cyclophosphamide rATG/HSCT | 2 | Participants | ||
| Number of Participants With Treatment Failure | Cyclophosphamide rATG/Fludarabine/HSCT | 2 | Participants | ||
| Survival of Treatment | Cyclophosphamide rATG/HSCT | 22 | Participants | ||
| Survival of Treatment | Cyclophosphamide rATG/Fludarabine/HSCT | 21 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cyclophosphamide rATG/HSCT | 22 | |
| Overall Study | STARTED | Cyclophosphamide rATG/Fludarabine/HSCT | 22 | |
| Overall Study | COMPLETED | Cyclophosphamide rATG/HSCT | 22 | |
| Overall Study | COMPLETED | Cyclophosphamide rATG/Fludarabine/HSCT | 22 | |
| Overall Study | NOT COMPLETED | Cyclophosphamide rATG/HSCT | 0 | |
| Overall Study | NOT COMPLETED | Cyclophosphamide rATG/Fludarabine/HSCT | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Plueral Effusion | Respiratory, thoracic and mediastinal disorders | Cyclophosphamide rATG/HSCT | 1 | 22 | 1 |
| other | Plueral Effusion | Respiratory, thoracic and mediastinal disorders | Cyclophosphamide rATG/Fludarabine/HSCT | 0 | 22 | 0 |
| other | Disease Related Pericardial Effusion | Cardiac disorders | Cyclophosphamide rATG/HSCT | 2 | 22 | 2 |
| other | Disease Related Pericardial Effusion | Cardiac disorders | Cyclophosphamide rATG/Fludarabine/HSCT | 2 | 22 | 2 |
| other | Cardiac Tamponade | Cardiac disorders | Cyclophosphamide rATG/HSCT | 0 | 22 | 0 |
| other | Cardiac Tamponade | Cardiac disorders | Cyclophosphamide rATG/Fludarabine/HSCT | 1 | 22 | 1 |
| serious | Scleroderma Disease Related | General disorders | Cyclophosphamide rATG/HSCT | 2 | 22 | 2 |
| serious | Scleroderma Disease Related | General disorders | Cyclophosphamide rATG/Fludarabine/HSCT | 3 | 22 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cyclophosphamide rATG/HSCT | 2 | 22 |
| Total, all-cause mortality | Cyclophosphamide rATG/Fludarabine/HSCT | 3 | 22 |
| Total, other adverse events | Cyclophosphamide rATG/HSCT | 3 | 22 |
| Total, other adverse events | Cyclophosphamide rATG/Fludarabine/HSCT | 2 | 22 |
| Total, serious adverse events | Cyclophosphamide rATG/HSCT | 2 | 22 |
| Total, serious adverse events | Cyclophosphamide rATG/Fludarabine/HSCT | 3 | 22 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Cyclophosphamide rATG/HSCT vs Cyclophosphamide rATG/Fludarabine/HSCT: Survival of Treatment | Trial comparisons |
| Cyclophosphamide rATG/HSCT vs Cyclophosphamide rATG/Fludarabine/HSCT: Number of Participants With Treatment Failure | Trial comparisons |
| Cyclophosphamide rATG/HSCT vs Cyclophosphamide rATG/Fludarabine/HSCT: deaths from any cause | Trial comparisons |
| Cyclophosphamide rATG/HSCT vs Cyclophosphamide rATG/Fludarabine/HSCT: 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/NCT01445821
GET https://conductscience.org/api/trials/v1/NCT01445821/registered