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Hyperbaric Oxygen Therapy for Leukemia Engraftment (HBO-UBC Trial)
HBO-UBC Trial Summary
This trial is testing whether the UCB transplant is more effective than the standard stem cell transplant for treating leukemia.
HBO-UBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHBO-UBC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HBO-UBC Trial Design
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Who is running the clinical trial?
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- I am over 45 or under 45 with a high HCT comorbidity index.I am between 18 and 70 years old.I have had a collapsed lung or significant lung scarring seen on scans within the last 2 months.I am able to care for myself but may not be able to do active work.You have a fear of enclosed spaces (claustrophobia).My leukemia is not in the early favorable-risk stage.I have had a collapsed lung without injury.My liver, kidneys, heart, and lungs are healthy enough for a transplant.My MDS/MPN shows less than 10% bone marrow blasts and no blood blasts.I need oxygen therapy for my severe COPD.I haven't had chemotherapy in the spine or brain radiation within the last month.I have not used tobacco for 72 hours before my transplant and will not until fully recovered.My Hodgkin's disease came back after strong treatment.I am considered for reduced-intensity conditioning treatment.I am eligible for a stem cell transplant but don’t have a matching donor or can't proceed within 8 weeks.I currently have an ear or sinus infection.I have had surgery or radiation therapy directly on my chest before.I have a history of seizures.I have not had sinus or ear surgery, except for ear tubes, in the last 5 years.My ALL is considered high-risk based on specific criteria.My non-Hodgkin's lymphoma responded to chemotherapy but returned after a high-dose treatment and stem cell transplant.
- Group 1: HBO arm
- Group 2: non-HBO 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
How many people are enrolled in this research project?
"Per the information available on clinicaltrials.gov, this study is still recruiting patients. The initial posting was on 2/28/2019, with the most recent update being on 4/7/2022. So far, 64 people have been recruited from 1 location."
Has the FDA sanctioned Hyperbaric oxygen for therapeutic use?
"While there is some clinical data indicating that hyperbaric oxygen is safe, it has not yet been proven effective. Therefore, it received a score of 2."
How can I sign up for the clinical trial?
"This clinical trial is looking for 64 patients with hodgkin disease between the ages of 18 and 70. In order to be eligible, applicants must meet the following criteria: - High white blood cell count at diagnosis (ie, >30,000/microL in B-ALL or >100,000/microL in T-ALL)- Voluntary written informed consent- Patients who are considered for allogeneic transplantation based on their disease risk but lack matched sibling or unrelated donors or who are unable to proceed to allogeneic transplant within 8 weeksRIC is considered in those older than 45"
Are participants still being sought for this experiment?
"Yes, this study is still open to new participants. The clinicaltrials.gov website shows that the last update was on April 7th, 2022 and the trial was originally posted on February 28th, 2019."
Would this study be appropriate for geriatric patients?
"This trial is only for patients aged 18-70. However, there are 323 other studies that young adults can enroll in and 1074 trials available for seniors."
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