CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 75 enrolled
Drug / intervention
mHSCT +1 morebiological
Likely dose
mHSCT arm: Total body irradiation 800 cGy, cyclophosphamide 120 mg/kg, ATGAM 90 mg/kg followed by autologous CD34+ hematopoietic progenitor transplantation; Cyclophosphamide arm: 500 mg/m² initial IV dose followed by 11 infusions of 750 mg/m² with mesnaAI-extracted
Key inclusion· 2
  • ✓Severe systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR)
  • ✓Extensive skin and internal organ involvement threatening life (lungs or kidneys affected)
Key exclusion· 10
  • ✕Prior cyclophosphamide exposure: >6 months IV use, cumulative IV dose >3 g/m², >4 months oral use, or combination >6 months total
  • ✕Active gastric antral vascular ectasia (GAVE; watermelon stomach)
  • ✕Significant lung, heart, liver, or kidney impairment that would compromise survival
  • ✕Steroid therapy >10 mg/day or >2 pulses within 12 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00114530
NCT00114530Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 16, 2005·Updated Apr 12, 2023

In Brief

A Phase 3 clinical trial evaluating mHSCT and cyclophosphamide for Scleroderma, Systemic and 2 related conditions. Completed, enrolled 75 participants across 17 sites in 2 countries.

Detailed Summary

SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScleroderma, Systemic, Sclerosis, Autoimmune Disease
CountriesCanada, United States
CollaboratorsRho Federal Systems Division, Inc.

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2005
Enrollment StartJun 1, 2005
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 21.0 years ago

Interventions

mHSCTbiological

Hematopoietic progenitors were mobilized with G-CSF. After leukapheresis and CD34+ cell enrichment, the autologous product was cryopreserved. Fractionated TBI (800 cGy), CY (120 mg/kg) and equine antithymocyte globulin (90 mg/kg) were administered as previously reported (References provided in citation section of this ClinicalTrials.gov record: PubMed ID: 17452515 citation and 2.) PubMed ID: 12176878 citation).

cyclophosphamidedrug

An initial intravenous dose of 500 mg/m\^2 was followed by 11 infusions of 750 mg/m\^2 with mesna given for bladder protection.