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Stem Cell Transplant with Conditioning Regimen for Blood Diseases
Study Summary
This trial will study whether a new, less intensive conditioning regimen using the drugs treosulfan, thiotepa, and fludarabine phosphate is just as effective in treating patients with nonmalignant diseases as the current standard of care, which uses more powerful and potentially more toxic chemotherapy drugs.
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?
Media Library
- My lung function is significantly reduced, as shown by tests or oxygen levels below 92%.I cannot have a bone marrow or stem cell collection procedure.I am a donor without active infectious hepatitis.My preferred cell source for donation is bone marrow, but peripheral blood stem cells may be used if needed.My kidney function is impaired, with specific test results confirming it.I am a female donor and my pregnancy test is positive.My bone marrow graft meets the required cell count.My donor matches me closely in immune system markers or has only one mismatch.I don't have antibodies against the donor's specific HLA.I have aplastic anemia, with or without PNH, but not Fanconi anemia.My liver is severely damaged, as confirmed by a specialist.I am under 50 years old.I am not pregnant or breastfeeding.My heart's pumping ability is reduced, or I have heart disease needing treatment.My stem cell graft has the right number of CD34 cells.I have a non-cancerous condition that can be treated with a stem cell transplant from a donor.My donor's cord blood unit hasn't passed infectious disease screening but can be used with a waiver.I have a sibling donor whose bone marrow and umbilical cord blood match mine.You are allergic to treosulfan, fludarabine, or thiotepa.My disease is not cancerous and its genetic cause is unknown, but I have PI approval.
- Group 1: Treatment (chemotherapy, transplant)
- 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
Has Allogeneic Hematopoietic Stem Cell Transplantation been cleared by the FDA?
"Allogeneic Hematopoietic Stem Cell Transplantation is currently in Phase 2 clinical trials. There is some evidence supporting its safety, but more research needs to be done to confirm efficacy."
What medical conditions has Allogeneic Hematopoietic Stem Cell Transplantation been shown to improve?
"Allogeneic Hematopoietic Stem Cell Transplantation is a medical procedure used to treat conditions such as chronic lymphocytic leukemia and cancer. This therapy can also be useful in hsct conditioning and urinary bladder treatments."
Can new patients still enroll in this research project?
"This clinical trial, which was originally posted on 5/5/2021 and most recently updated on 10/25/2022, is actively recruiting participants."
Are there any other ongoing or completed medical studies involving Allogeneic Hematopoietic stem cell transplants?
"There are 31 Phase 3 trials and 413 active trials in total for Allogeneic Hematopoietic Stem Cell Transplantation. The majority of these clinical trials are based in Boston, however there are 4797 locations running similar studies."
How many people fit the qualifications for this experiment?
"The most recent information available on clinicaltrials.gov suggests that this study is still enrolling patients. The trial was first posted on May 5th, 2021 and has been edited as recently as October 25th, 2022. This study needs 40 more patients from 2 different medical centres in order to complete its planned enrolment."
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