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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 is a Phase 3 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 44 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445821
The ClinicalTrials.gov registry entry for NCT01445821 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01445821 reports 0 study locations.
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.
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