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Stem Cell Transplant for Severe Aplastic Anemia
Study Summary
This trial is for people with severe aplastic anemia, myelodysplastic syndrome, or paroxysmal nocturnal hemoglobinuria who want to receive a stem cell transplant using peripheral blood stem cells from a family member.
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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- I have been diagnosed with severe aplastic anemia.I don't have antibodies against the donor's tissue markers.Your direct bilirubin level is higher than 3 mg/dl.I have an infection that isn't getting better with treatment.I have a family member who is a near-perfect match for a stem cell donation.I have been diagnosed with Fanconi's anemia.Your blood creatinine level is higher than 2.5 mg/dl.My heart's pumping ability is significantly reduced.Your lungs have difficulty transferring carbon monoxide.I do not have any major illnesses or organ failures that would prevent me from surviving a transplant.I am eligible for a stem cell transplant from a fully matched donor.I need some help with my daily activities.I am not pregnant and willing to use birth control or abstain for a year.My kidney function is reduced, with a creatinine clearance rate below 50.My PNH does not respond to eculizumab/ravulizumab or I can't access this treatment.My severe aplastic anemia has turned into MDS.I have a severe bone marrow condition and standard treatments haven't worked for me.I understand this study is experimental and I (or my guardian) can consent.I have a family member who can donate stem cells and is a partial HLA match.I have a history of cancer that could come back or get worse within 5 years.I am between the ages of 4 and 55.You have HIV.Your transaminase levels are more than 5 times the normal limit.
- Group 1: Treatment Arm
- 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 is the current capacity for enrolment in this experiment?
"Affirmative, clinicaltrials.gov confirms that this experiment is searching for participants; the protocol was initially published on February 19th 2019 and has been modified most recently on October 31st 2022. The research necessitates 56 individuals at a single location."
What diseases typically respond best to Cyclophosphamide treatment?
"Cyclophosphamide has proven successful in treating multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."
Are the criteria for enrollment in this clinical trial limited to persons under 35 years of age?
"This trial is recruiting participants aged between 4 and 75 years."
Has the FDA approved Cyclophosphamide for use?
"As this is a phase 2 clinical trial, which delivers evidence of safety but not efficacy, Power allocated Cyclophosphamide with a score of 2."
Does this clinical experiment have any open recruitment slots?
"Affirmative. Clinicaltrials.gov has posted that this research initiative, which was initially announced on February 19th 2019 is actively looking for participants. 56 individuals are needed from a single site in order to be able to conduct the trial successfully."
Who is eligible to join this clinical experiment?
"This clinical trial is enrolling 56 individuals, aged 4 to 75 years old, who have been diagnosed with preleukemia. Other qualifications to join the study include: having Paroxysmal Nocturnal Hemoglobinuria (PNH) that has not responded well to eculizumab/ravulizumab treatment or being denied access; possessing a stem cell donor between 6 and 75 years of age who meets certain human leukocyte antigen requirements; or previously experiencing extreme Aplastic Anemia which then advanced into Myelodysplastic syndrome with an International Prognostic Scoring System risk greater than INT-1 as"
Have any other investigations looked into the effects of Cyclophosphamide?
"Presently, Cyclophosphamide has 816 active research studies with 154 of them in the later stages. The majority of these investigations are conducted in Philadelphia, Pennsylvania, but there a plethora of locations throughout the country contributing to this data set."
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