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Immunosuppressant
Stem Cell Transplant for Scleroderma (STAT Trial)
Phase 2
Waitlist Available
Led By Leona Holmberg
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with SSc as defined by the American College of Rheumatology with diffuse cutaneous disease (except Group 5) at risk of disease progression
Patients must have failed a prior >= 4-month course of either MMF/Myfortic or cyclophosphamide before being eligible for the study (determined at >= 1 week before start of mobilization); 'failure' is defined as evidence of disease progression or absence of improvement; the response prior to MMF of cyclophosphamide will be assessed by the participating site study rheumatologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 5
Awards & highlights
STAT Trial Summary
This trial is studying how well giving cyclophosphamide and anti-thymocyte globulin together followed by a stem cell transplant and mycophenolate mofetil works to treat patients with systemic scleroderma.
Who is the study for?
This trial is for patients with systemic scleroderma, specifically those who have had the disease for less than two years with severe skin involvement or lung problems, and those not responding to standard treatments. It's not open to individuals with a life expectancy under five years, prior stem cell transplants, uncontrolled infections, recent cancers (except certain skin cancers), GAVE ('watermelon stomach'), smokers in the last three months, pregnant women, or those unable to consent.Check my eligibility
What is being tested?
The STAT study tests whether a combination of high-dose cyclophosphamide and anti-thymocyte globulin followed by autologous hematopoietic stem cell transplantation can treat systemic scleroderma. After transplanting the patient's own stored stem cells back into their body post-chemotherapy and immunosuppression therapy, maintenance therapy with mycophenolate mofetil is used to prevent worsening of SSc.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk; reactions from infusions; organ inflammation due to high-dose chemotherapy; blood count abnormalities; fatigue; digestive issues from medications like mycophenolate mofetil; and complications related to bone marrow suppression.
STAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have systemic sclerosis with skin involvement, not in Group 5, at risk of getting worse.
Select...
My condition did not improve after 4+ months on MMF/Myfortic or cyclophosphamide.
Select...
My gastrointestinal condition is getting worse.
Select...
I have scleroderma affecting my skin and lungs, with reduced lung function.
Select...
I have diffuse scleroderma, diagnosed within the last 2 years, with a severe skin condition.
Select...
I have diffuse scleroderma, diagnosed within the last 2 years, with severe skin thickening.
STAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
EFS of patients undergoing chemotherapy and transplant
Secondary outcome measures
Perinatal death
Change in cardiac function
Change in renal function over time
+15 moreSTAT Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (HDIT autologous PBSCT)Experimental Treatment10 Interventions
STEM CELL MOBILIZATION AND PREPARATION: Patients receive filgrastim SC on mobilization days 1-4 followed by apheresis until a target dose of CD34+ cells >= 2.5 x 10^6/kg are collected. Patients difficult to mobilize with filgrastim alone receive cyclophosphamide IV or *plerixafor SC on mobilization days 1-2 and filgrastim SC on mobilization days 5-7.
HDIT CONDITIONING: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days -5 to -2 and anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5.
TRANSPLANTATION: Patients undergo autologous PBSCT on day 0.
MAINTENANCE THERAPY: Beginning 2-3 months after transplant, patients receive mycophenolate mofetil PO BID for 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~720
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Cyclophosphamide
1995
Completed Phase 3
~3780
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Filgrastim
2000
Completed Phase 3
~3670
Anti-Thymocyte Globulin
2009
Completed Phase 4
~980
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,224 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,247 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lung, heart, liver, or kidney problems that could affect my treatment.I cannot or will not stop taking certain medications for my scleroderma.I have had a stem cell transplant using my own cells.I have systemic sclerosis with skin involvement, not in Group 5, at risk of getting worse.My condition did not improve after 4+ months on MMF/Myfortic or cyclophosphamide.My gastrointestinal condition is getting worse.I have scleroderma affecting my skin and lungs, with reduced lung function.I haven't had cancer, except for certain skin cancers or early-stage cancers, in the last 2 years.I have other serious health conditions with a life expectancy of less than 5 years.I do not have any severe infections that cannot be controlled.I have an active or significant case of 'watermelon stomach'.I have diffuse scleroderma, diagnosed within the last 2 years, with a severe skin condition.I am unable to understand and give consent for treatment.You have smoked tobacco or related products in the last 3 months.My lung function has worsened in the last 18 months.I have diffuse scleroderma, diagnosed within the last 2 years, with severe skin thickening.I have an autoimmune disease that doesn't require strong immune-suppressing drugs.I have been tested for MDS due to my cancer treatment history.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (HDIT autologous PBSCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any previous research studies that have explored the effects of Peripheral Blood Stem Cell Transplantation?
"Peripheral Blood Stem Cell Transplantation was first explored in 1997 at the City of Hope Comprehensive Cancer Center, and since then 2451 clinical trials have been conducted. At present 994 more are actively enrolling participants; a notable amount of these studies originate from Seattle, Washington."
Answered by AI
What medical conditions is Peripheral Blood Stem Cell Transplantation typically utilized to address?
"Peripheral Blood Stem Cell Transplantation is a potent therapy for lung cancer, as well as mobilization of hematopoietic stem cells, immunosuppressive treatment, and multiple sclerosis."
Answered by AI
How many participants has the research team welcomed into this study thus far?
"This medical trial is not presently enrolling patients. The original posting date was September 15th 2011 with the last update on July 18th 2022. For those seeking alternative trials, there are 81 studies related to scleroderma and systemic diseases actively recruiting as well as 994 clinical trials exploring Peripheral Blood Stem Cell Transplantation that require participants."
Answered by AI
Is this research program still accessible to volunteers?
"According to the clinicaltrials.gov, this medical study is not presently recruiting patients; it was initially posted on September 15th 2011 and last updated July 18th 2022. Nevertheless, there are a whopping 1075 other trials that have open enrollment right now."
Answered by AI
Has the FDA given their endorsement for Peripheral Blood Stem Cell Transplantation?
"According to the assessment by Power, the safety of Peripheral Blood Stem Cell Transplantation was rated a 2. This is due to it being in Phase 2 trial status with some evidence on its safety but no data supporting efficacy."
Answered by AI
How many locations are presently engaged in this experiment?
"At present, the trial has been established in 12 locations including Seattle, Durham and Denver. To reduce transportation costs for those wishing to partake, it is advised that they choose a site closest to them."
Answered by AI
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