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NCT01445821 · ClinicalTrials.gov registry record · Phase 3
Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial
A Phase 3 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT01445821: Clinical Trial Phase 3 study, sponsored by Northwestern University.
NCT01445821 is a Phase 3 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 44 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445821, a Phase 3 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study Summary
ASSIST I was the first randomized trial in patients with scleroderma to not just slow disease progression but rather actually reverse it. It is the first treatment to have ever demonstrated reversal of lung disease in scleroderma with improvement in FVC, total lung capacity (TLC), high-resolution computed tomography (HRCT), and QOL. We now, therefore, purpose to compare the ASSIST I conditioning regimen of cyclophosphamide and rATG to a less intense regimen of rATG/cyclophosphamide/Fludarabine. In the new regimen the cyclophosphamide dose is decreased to 120mg/kg (60mg/kg/day x 2) compared to 200mg/kg (50mg/kg/day) in the standard regimen. The lower dose of cyclophosphamide will be less cardiotoxic. This study will determine if the less cardiotoxic regimen will be safer than the standard regimen and as effective as the standard regimen.
Primary Outcome
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
Interventions
- DRUG Cyclophosphamide
- DRUG Mesna
- DRUG Methylprednisolone
- DRUG rATG
- BIOLOGICAL Peripheral Blood Stem Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2011-09-15 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 3 |
Why NCT01445821 stopped before completion
NCT01445821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01445821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01445821 about?
NCT01445821 is a clinical study titled "Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial". ASSIST I was the first randomized trial in patients with scleroderma to not just slow disease progression but rather actually reverse it. It is the first treatment to have ever demonstrated reversal of lung disease in scleroderma with improvement in FVC, total lung capacity (TLC), high-resolution co...
What is the current status of trial NCT01445821?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2011-09-15. Estimated completion is 2019-10-10.
What interventions are being tested in trial NCT01445821?
The interventions under investigation include: Cyclophosphamide (DRUG), Mesna (DRUG), Methylprednisolone (DRUG), rATG (DRUG), Peripheral Blood Stem Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01445821?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01445821's enrollment target sits among peer trials
44 1874th of 2000 higher than 125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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