Clinical Trials Logo
  1. Home
  2. Scleroderma, Systemic
  3. NCT01445821

Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial — DIScl2011  

Scleroderma, Systemic Clinical Trial

Official title:
Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb)

Clinical Trial 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.

Clinical Trial Description

Mobilization. For patients in both arms undergoing hematopoietic stem cell transplantation (HSCT), peripheral blood stem cells (PBSC) will be mobilized with cyclophosphamide (2 g/m2) followed by 5-10 mcg/kg subcutaneous filgrastrim daily from day 5 until completion of apheresis. Mobilized hematopoietic stem cells (HSC) will be collected by apheresis on day 10 and cryopreserved without selection or manipulation. There will be an interval of at least 17 days between mobilization of PBSC and start of conditioning regimen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01445821
Study type Interventional
Source Northwestern University
Contact
Status Terminated
Phase Phase 3
Start date September 15, 2011
Completion date October 10, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03965780 - The SPIN - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED) N/A
Terminated NCT02558543 - Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis Phase 2
Withdrawn NCT01202045 - Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients N/A
Recruiting NCT05878717 - A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease Phase 3
Recruiting NCT03559465 - Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis. N/A
Not yet recruiting NCT03610217 - Pragmatic Clinical Trials in Scleroderma N/A
Completed NCT02655640 - The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis N/A
Completed NCT05622578 - Phenotyping of Chronic Pain in Diffused Systemic Scleroderma N/A
Recruiting NCT04804930 - Trichoscopy and Systemic Scleroderma
Completed NCT03675581 - A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) Phase 1
Completed NCT03221257 - Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate Phase 2
Recruiting NCT05559580 - A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms Phase 2
Completed NCT00442611 - A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma) Phase 1/Phase 2
Completed NCT00001330 - Study of Silicone-Associated Connective Tissue Diseases N/A
Completed NCT02597933 - A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis Phase 3
Not yet recruiting NCT05821335 - Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis N/A
Completed NCT00333437 - Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement N/A
Completed NCT00025818 - Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome Phase 3
Not yet recruiting NCT05351060 - Novel Splinting Technique Using 3D Models N/A
Not yet recruiting NCT04563481 - Effectiveness of Telerehabilitation on Scleroderma N/A