Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients (NCT00040651) | Clinical Trial Compass
TerminatedPhase 1
Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients
United States15 participantsStarted 2002-07
Plain-language summary
Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe SSc.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ECOG performance status of 0 to 2
* Willing to participate in all portions of the protocol, including pharmacodynamic and immunologic studies and patient care follow-up visits
* Willing to stay in the Pittsburgh area for 100 days post-transplantation
* Willing to use acceptable methods of contraception
Exclusion Criteria:
* HIV infected
* Hepatitis C virus infected
* Active infection
* Small malabsorption syndrome
* Immunosuppressive therapy other than steroids within 4 weeks of study entry
* Pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Non-hematologic toxicity experienced
Timeframe: Measured within 3 weeks after transplant
Trial details
NCT IDNCT00040651
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)