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Personalized rATG for Leukemia
Study Summary
This trial will test if a conditioning regimen that includes P-rATG helps the immune system recover sooner and decreases the chances of transplant-related side effects.
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 am between 2 and 12 years old.My organs are functioning well.I am physically active and can care for myself.My heart's pumping ability is normal or above normal.I can undergo a procedure to reduce tumor size.I am 16 or older and mostly can take care of myself.I am a male aged 13-21 years.I am not pregnant or breastfeeding.I have an active brain or spinal cord tumor.My kidney function is within the required range for the trial.I am a female aged 13-21 years.My leukemia is in remission and minimal residual disease is under 5%.My risk score is intermediate or higher for my condition.I do not have any infections that are currently not under control.I am between 4 and 60 years old.I have MDS with at least one specific condition.My lung function tests are above 50% of what's expected, or my oxygen levels are above 92% without extra oxygen.I am under 16 and mostly active.I am getting a specific stem cell transplant for my blood cancer.I am of the required age for the trial.I have a severe blood cell count issue.I am able to give informed consent and follow the treatment plan.My child's cancer does not show signs of minimal residual disease.My kidney function is normal for my age.I have had a stem cell transplant from a donor.My tests show genetic changes that could lead to a severe type of leukemia.My age does not limit my participation in Regimen B.My AML is in early remission or a later relapse, with minimal remaining disease.My leukemia is in remission but at high risk of returning, or it's in its second or later remission.My bilirubin levels are 2 mg/dL or lower, or I have a condition that causes high bilirubin.My condition is not a result of treatment for another cancer.My cancer has spread outside the bone marrow.
- Group 1: P-rATG with total body irradiation, thiotepa, cyclophosphamide
- Group 2: P-rATG with busulfan, melphalan and fludarabine
- 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 the FDA sanctioned Personalized rATG (P-rATG)?
"Although there is limited evidence of P-rATG's efficacy, it has garnered a score of two due to the prior clinical data that supports its safety."
Could you provide information on prior experiments related to Personalized rATG (P-rATG)?
"Presently, there are 967 active trials researching the efficacy of Personalized rATG (P-rATG). Of these studies, 171 have advanced to Phase 3. Philadelphia is home to the most research centers regarding P-rATG with 29720 other locations hosting clinical trial sites for this medication."
How many individuals have been selected to participate in this investigation?
"Affirmative. According to the available information on clinicaltrials.gov, this medical trial is still accepting participants as of today's date. It was first posted back on April 30th 2021 and has been updated most recently on August 31st 2022. The research initiative requires 56 volunteers at a single site for completion."
Does this investigation still accept enrollees?
"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting participants and was initially publicized on April 30th 2021. The most recent update was provided August 31st 2022. 56 volunteers need to be recruited at a single site for the study's completion."
For what conditions is Personalized rATG (P-rATG) commonly prescribed?
"Personalized rATG (P-rATG) is regularly prescribed to patients with multiple sclerosis and can be helpful in managing various ailments such as acute myelocytic leukemia, chronic myelogenous leukemia, thrombocythemia, essential, and allogeneic hematopoietic stem cell transplants."
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