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RIC alloBMT + Cyclophosphamide for Scleroderma
Study Summary
This trialstudies safety of reduced intensity BMT w/ cyclophosphamide to treat scleroderma. Eligibility includes adults with active diffuse cutaneous disease. Effects on skeletal & cardiac muscles will also be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I have not received a live vaccine in the last 4 weeks.I am a male and follow the required contraceptive measures.You have had hepatitis C and it was not successfully treated.I have widespread skin disease with noticeable symptoms.I am following the required birth control measures.You are currently using drugs or alcohol regularly or have a dependency on them.My cancer is growing or needs treatment now.You have had severe allergic reactions or intolerances to certain substances in the past.You have a history of HIV, hepatitis B or C, or any other contagious disease.I am currently on or expect to start immunosuppressive therapy.I have no significant health issues other than scleroderma.I have not had major surgery or radiation therapy in the last 4 weeks.My heart, liver, kidneys, and lungs are working well.I am eligible for a bone marrow transplant according to the policy.You have been diagnosed with systemic sclerosis according to specific criteria set by medical organizations.I have severe lung disease.I have moderate-to-severe systemic sclerosis.Patients who are very close to the end of life.My diabetes is not under control, with an HbA1C over 8%.I am mostly independent and can care for myself.My first cancer treatment did not work.I am between 18 and 65 years old.I have had a kidney injury in the last 6 weeks.I do not have any unmanaged ongoing illnesses.I have certain heart and lung conditions.
- Group 1: RIC- alloBMT with high PTCy in SSc
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
To whom is this clinical research accessible?
"This medical trial requires that applicants possess progressive systemic sclerosis and are between 18 to 65 years of age. At the moment, roughly 30 people need to be recruited for participation."
Does this clinical research endeavor accept participants aged 20 and above?
"This clinical trial is only open to individuals aged 18-65. Those under 18 have 47 trials available, whereas those over 65 can participate in 353 different medical studies."
How many participants is the trial accommodating at this time?
"Affirmative. Clinicaltrials.gov's data implies that this medical trial is recruiting participants at present; the study was originally listed on November 18th 2022 and updated most recently on January 9th 2023. A total of 30 patients are required for one site to complete the research."
Has the FDA granted approval for RIC-alloBMT with high PTCy in SSc?
"Given that this is a first-phase trial, with limited clinical evidence to support safety and efficacy of RIC-alloBMT with high PTCy in SSc, our team at Power has rated it as 1 on the risk scale."
Are recruitment efforts ongoing for this research project?
"Affirmative. The information on clinicaltrials.gov implies that the recruitment phase of this trial is currently underway, having first been posted on November 18th 2022 and most recently edited January 9th 2023. A total of 30 participants are needed from a single research centre."
What are the hoped-for outcomes of this research endeavor?
"This medical trial, running for about 12 months in total, is examining how much Disease relapse or progression occurs. Secondary goals include Event free survival- increased mRSS scoring in diffuse scleroderma patients (number of participants initially diagnosed with this disease whose mRSS score increases by 5 points), Event free survival- transplant related death (how many participants die due to the transplant) and Event free survival- pulmonary function assessment (those who suffer a 10% decrease in FVC or both 5-10% drop plus 15% reduction in DLCO)."
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