Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114530
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2005-06-15
Brief Title:
Scleroderma Cyclophosphamide or Transplantation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation Cyclophosphamide ATGAM and Autologous Transplantation With Auto-CD34HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis SCSSc-01
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCOT
Brief 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
Detailed Description:
Severe systemic sclerosis SSc is a serious autoimmune disorder in which a persons own immune cells attack organs in the body SSc affects the skin joints lungs heart intestinal tract and kidneys and half of the patients with the most severe organ involvement die within 5 years Treatment for SSc usually includes supportive care or immunosuppressive drugs drugs to suppress the immune system As the immune cells are believed to be causing the disease researchers are looking for new therapies that either slow down or stop this process while not being too toxic
The main purpose of this study is to determine the safety and effectiveness of high-dose immunosuppressive therapy followed by reinfusion transplantation of the participants own autologous self peripheral blood stem cells PBSCs compared to treatment with monthly for 12 months intravenous doses of cyclophosphamide Cytoxan therapy for the treatment of severe systemic sclerosis SSc These treatments are being given in order to determine if they will slow down or stop SSc from becoming more severe and if they can reverse the effects of the disease The researchers are evaluating the effects of the two treatments on serious organ damage and survival related to SSc while also looking at the side effects of the two treatments
This trial also includes three optional mechanistic sub-studies open to a subset of participants enrolled in the SCOT trial
1 Pharmacokinetics of 4-hydroxycyclophosphamide in Patients Receiving Cyclophosphamide for the SCOT trial Originally listed separately as DAIT SCSSc-01-01 NCT00848614 The purpose of this study is to determine the plasma concentration and exposure time required for cyclophosphamide to produce optimal immunosuppressive activity with minimal toxicity in participants with severe systemic sclerosis
2 Vascular Progenitor Cells and the Pathogenesis of Systemic SclerosisOriginally listed separately as DAIT SCSSc-01-02 NCT00871221 The purpose of this study is to measure and characterize the circulating endothelial progenitor cells from the blood of 30 participants and also to determine the extent of vascular cell apoptosis and proliferation in cutaneous microvasculature in these participants before and after the receipt of the two SCOT treatment regimens
3 Molecular Analysis of T Cell Immune Recovery for the SCOT TrialOriginally listed separately as DAIT SCSSc-01-03 NCT00872508 The purpose of this study is 1 to describe the condition of peripheral T cell reactivity and repertoire diversity in SSc patients and evaluate evidence for potential defects prior to randomization 2 to gain a better understanding of the impact of cyclophosphamide Cytoxan and high-dose immunosuppressive therapy with autologous stem cell transplantation on thymopoiesis and 3 to describe the kinetics and breadth of T cell immune recovery in SSc patients treated with these interventions
The main purpose of this study is to determine the safety and effectiveness of high-dose immunosuppressive therapy followed by reinfusion transplantation of the participants own autologous self peripheral blood stem cells PBSCs compared to treatment with monthly for 12 months intravenous doses of cyclophosphamide Cytoxan therapy for the treatment of severe systemic sclerosis SSc These treatments are being given in order to determine if they will slow down or stop SSc from becoming more severe and if they can reverse the effects of the disease The researchers are evaluating the effects of the two treatments on serious organ damage and survival related to SSc while also looking at the side effects of the two treatments
This trial also includes three optional mechanistic sub-studies open to a subset of participants enrolled in the SCOT trial
1 Pharmacokinetics of 4-hydroxycyclophosphamide in Patients Receiving Cyclophosphamide for the SCOT trial Originally listed separately as DAIT SCSSc-01-01 NCT00848614 The purpose of this study is to determine the plasma concentration and exposure time required for cyclophosphamide to produce optimal immunosuppressive activity with minimal toxicity in participants with severe systemic sclerosis
2 Vascular Progenitor Cells and the Pathogenesis of Systemic SclerosisOriginally listed separately as DAIT SCSSc-01-02 NCT00871221 The purpose of this study is to measure and characterize the circulating endothelial progenitor cells from the blood of 30 participants and also to determine the extent of vascular cell apoptosis and proliferation in cutaneous microvasculature in these participants before and after the receipt of the two SCOT treatment regimens
3 Molecular Analysis of T Cell Immune Recovery for the SCOT TrialOriginally listed separately as DAIT SCSSc-01-03 NCT00872508 The purpose of this study is 1 to describe the condition of peripheral T cell reactivity and repertoire diversity in SSc patients and evaluate evidence for potential defects prior to randomization 2 to gain a better understanding of the impact of cyclophosphamide Cytoxan and high-dose immunosuppressive therapy with autologous stem cell transplantation on thymopoiesis and 3 to describe the kinetics and breadth of T cell immune recovery in SSc patients treated with these interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID CRMS ID 20133 | OTHER | DAIT NIAID | None |