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Gene Modified T-cells + Stem Cell Transplant for Leukemia
Study Summary
This trial will evaluate whether adding T cells back to stem cells from a partially matched relative can help the immune system recover post-transplant.
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 had a stem cell transplant using my own cells less than 3 months ago.I am HIV positive.I do not have any ongoing serious infections.I have had a stem cell transplant from a donor.I have been diagnosed with primary idiopathic myelofibrosis.I am eligible for a stem cell transplant from a donor.I don't have a matching donor or my disease is worsening too quickly.My donor and I share at least one genetic match in specific areas.My heart, liver, kidneys, and lungs are functioning well.I have been diagnosed with a specific blood cancer.I am able to care for myself but may not be able to do active work.I have a donor who is a perfect match for my transplant.My blood cancer hasn't responded to standard treatments, and the trial sponsor has approved my participation.I haven't had cancer other than skin cancer in the last 3 years.I am between 18 and 65 years old.My HLA typing matches at least half of the required markers.
- Group 1: SCT, BPX-501 dose 4, Rimiducid if needed
- Group 2: SCT, BPX-501 dose 1, Rimiducid if needed
- Group 3: SCT, BPX-501 dose 2, Rimiducid if needed
- Group 4: SCT, BPX-501 dose 3, Rimiducid if needed
- 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
Is enrollment for this trial still open?
"At present, this trial is not enrolling new participants. It was posted on the 1st of March 2013 and revised for the last time on July 10th 2022. If you are seeking out other studies to join, there are 3086 clinical trials available that accept patients with myelodysplastic syndromes while 16 trials actively admit those treated with Rimiducid."
Who qualifies as a suitable participant for this clinical research?
"This trial is currently enrolling 36 people aged between 18 and 65 who exhibit myelodysplastic syndromes. Furthermore, patients must satisfy other important criteria such as providing informed consent for the procedure, being eligible for allogeneic stem cell transplantation, lacking a suitable donor or showing signs of rapidly progressing disease that cannot be addressed by an unrelated donor, having HLA-A to DRB1 alleles at least 4/8 identical with those of the recipient's genotype through high resolution typing, exhibiting left ventricular ejection fraction rest higher than 45%, presenting bilirubin levels below 2.5 mg/dL"
What is the ambition behind this clinical exploration?
"This 24-month clinical trial will measure the safety of BPX-501. Additionally, researchers will assess efficacy and relapse rate, time for resolution of acute GvHD post Rimiducid administration, as well as incidence and severity of both acute and chronic GvHD."
Is the participation of individuals aged 40 and above being solicited for this research endeavor?
"This trial is accepting patients ages 18 to 65 only. For those that are younger or older, 679 and 2681 research studies offer alternative options respectively."
Have any other investigations been done on Rimiducid's efficacy?
"Currently, 16 Rimiducid trials are active with none in the third phase. San Diego is a hub for these types of studies, but there are 94 other sites worldwide facilitating clinical research related to this drug."
In which geographic locations is this research project active?
"This trial is being conducted across 8 different centres, located in cities such as Buffalo, Cleveland and Portland. Participants are encouraged to select the site closest to them for convenience's sake."
How many participants is this inquiry seeking to include?
"Unfortunately, the recruitment process for this trial has currently stalled. It was first listed on March 1st 2013 and last modified on July 10th 2022. On the other hand, there are 3086 studies actively enrolling patients with myelodysplastic syndromes and 16 clinical trials utilizing Rimiducid that have open spots available."
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