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Stem Cell Transplant Prep Regimen for Immune Deficiency Disorders
Study Summary
This trial is testing a new, less intense immunosuppressive regimen to see if it can establish engraftment of donor hematopoietic cells while still being safe.
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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Who is running the clinical trial?
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- Your blood creatinine levels are within a certain range.I have not had an uncontrolled viral infection in the week before starting alemtuzumab.Your liver enzymes are not more than 5 times the normal upper limit.Your heart is pumping normally, with a strong enough force.I am 28 years old or younger.You must have a negative pregnancy test.I haven't had severe fungal or bacterial infections in the last month.I have been diagnosed with HIV.Your DLCO (lung function test) is equal to or more than 40%.I am mostly bedridden due to my health condition.I have a donor that matches the required criteria for a transplant.
- Group 1: Preparative
- 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
What conditions are typically addressed by the Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa and melphalan?
"Alemtuzumab, fludarabine, thiotepa and melphalan can be used as a transplant preparative regimen to treat multiple sclerosis. It is also known to successfully manage cancer, rejection of transplants, kidney issues and b-lymphocyte related disorders."
What prior investigations have been conducted on the effects of combining alemtuzumab, fludarabine, thiotepa and melphalan as part of an organ Transplant preparative regimen?
"Alemtuzumab, fludarabine, thiotepa and melphalan was first tested as a transplant preparative regimen in 1997 at the City of Hope Comprehensive Cancer Center. Since then there have been 665 trials completed with an additional 481 active clinical sites - many located within Saint Louis, Missouri."
Has the US Food and Drug Administration sanctioned a Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan?
"With evidence of safety but no proof of efficacy, our team at Power assigned Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa and melphalan a score of 2 on the risk scale."
How many individuals have enrolled in the clinical trial to date?
"Yes, according to the information on clinicaltrials.gov, this medical trial is actively seeking enrolment from patients at present. It was first posted on March 1st 2013 and has been amended as recently as April 25th 2022. The experiment requires 20 participants divided between two sites for proper data collection."
Is this experiment accessible to prospective participants at the moment?
"As per the information hosted on clinicaltrials.gov, this study is currently recruiting patients for participation. It was first advertised on March 1st 2013 and more recently updated April 25th 2022."
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