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NCT01413100 · ClinicalTrials.gov registry record · Phase 2
Scleroderma Treatment With Autologous Transplant (STAT) Study
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01413100: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT01413100 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01413100, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the patient's blood and stored prior to treatment. To store the stem cells patients are given colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to help stem cells move from the bone marrow to the blood so they can be collected and stored. After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for the transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells have "engrafted" and have matured enough to support the immune system at approximately 2-3 months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This medication is given to prevent worsening or reactivation of SSc and is referred to as maintenance therapy.
Primary Outcome
Event Free Survival (EFS) was defined as survival without meeting the protocol defined endpoint of organ injury (kidney injury requiring renal replacement dialysis for \>6 months, sustained LVEF \<30%, or sustained decline of FVC \>20%).
Interventions
- DRUG Cyclophosphamide
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Anti-Thymocyte Globulin
- BIOLOGICAL Filgrastim
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-09-15 |
| Est. Completion | 2024-09-11 |
| Phase | Phase 2 |
What the finished NCT01413100 record still lists
NCT01413100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01413100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01413100 about?
NCT01413100 is a clinical study titled "Scleroderma Treatment With Autologous Transplant (STAT) Study". This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the patient's blood and stor...
What is the current status of trial NCT01413100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2011-09-15. Estimated completion is 2024-09-11.
What interventions are being tested in trial NCT01413100?
The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Anti-Thymocyte Globulin (BIOLOGICAL), Filgrastim (BIOLOGICAL), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01413100?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01413100's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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