Trial · NCT03630211
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | High Dose Immunoablative therapy-Safety | Up to 36 months post HSCT | Safety will be determined by monitoring for death of any cause, regimen-related toxicities, and severe or life-threatening infections. |
| Primary | Death | Post Transplant through study completion, an average of 36 months | How many, if any, patients die |
| Primary | Respiratory Failure | Post Transplant through study completion, an average of 36 months | defined by one of the following 3 criteria without explanation for causation other than disease progression: 1. decline in DLCO of ≥30% or FVC≥20% as measured by actual difference in percent predicted units; 2. Resting arterial p02 \< 60 mmHg or pCO2 \> 50 mmHg supplemental oxygen;3. Resting pulse oximetry of 88% or lower measured by forehead probe. |
| Primary | Renal Failure | Post Transplant through study completion, an average of 36 months | Defined by chronic dialysis for \>6 months or renal transplantation |
| Primary | The occurrence of cardiomyopathy | Post Transplant through study completion, an average of 36 months | confirmed by clinical congestive heart failure (New York Heart Association) or LVEF (left ventricular ejection fraction) \<30% on echocardiogram |
| Primary | Treatment-related mortality (TRM) | Mobilization through study completion, an average of 36 months | defined as death occurring at any time after stem cell mobilization and definitely or probably resulting from treatment given in the study. TRM will be determined yearly with a focus on the first 2 years. |
| Primary | High Dose Immunoablative therapy-Treatment Effect | up to 36 months post HSCT (hematopoietic stem cell transplantation) | Treatment effect will be determined by assessing event-free survival in comparison to a SSc observational cohort control group treated with standard of care medication (mycophenolate mofetil) at 12 and 36 months post hematopoietic stem cell transplant (HSCT). |
| Secondary | An increase of mRSS (modified Rodnan skin score ) by ≥5 points for skin score | Disease response will be defined as subject improvement. This will be assessed for both skin and interstitial lung disease at 12 and 24 months post-HSCT. | To assess cutaneous response the modified Rodnan skin score (mRSS) will be used. |
| Secondary | Increase by ≥25% if the baseline mRSS > 20. | Disease response will be defined as subject improvement. This will be assessed for both skin and interstitial lung disease at 12 and 24 months post-HSCT. | To assess cutaneous response the modified Rodnan skin score (mRSS) will be used. |
| Secondary | Worsening of > 10% of FVC (pulmonary function testing) | 1 year post transplant through study completion, an average of 36 months | to evaluate interstitial lung disease an increase of ≥15% in DLCO or ≥10% of FVC (actual change in % predicted units from baseline) sustained for ≥3 months on 2 determinations. |
| Secondary | Decrease in DLCO sustained for 3 months or longer on pulmonary function tests (PFT) | 1 year post transplant through study completion, an average of 36 months | to evaluate interstitial lung disease an increase of ≥15% in DLCO or ≥10% of FVC (actual change in % predicted units from baseline) sustained for ≥3 months on 2 determinations. |
| Secondary | Worsening of cardiac involvement | Post Transplant through study completion, an average of 36 months | With use of Imaging, EKG, Echocardiogram, Cardiac MRI, right heart cauterization, implanted loop recorder and 2 week cardiac event monitor. Defined as new or worsening arrhythmias that require medical treatment of 3 months or longer, or require ablative therapy, pacemaker or defibrillator insertion or defined as a decline in ejection fraction of ≥10 EF units, determined by echocardiogram. |
| Secondary | Development of scleroderma renal crisis (hypertensive or non-hypertensive) | Post Transplant through study completion, an average of 36 months | Hypertensive renal crisis can be defined as a rise in SBP ≥ 30 points or DBP ≥ 20 points from baseline and one of the following: 1) Increase in baseline serum creatinine of ≥ 50%, 2) thrombocytopenia \< 100,000 plts/mm3 or 3. hemolysis by blood smear or increased reticulocyte count. |
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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