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Hyperbaric Oxygen Therapy for Leukemia Engraftment (HBO-UBC Trial)
Phase 2
Recruiting
Led By Omar Aljitawi
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Minimum criteria include: ALT, AST: < 4x IULN, Total bilirubin: ≤ 2.0 mg/dL, Creatinine: ≤ 1.5 x ULN, EF measured by 2D-ECHO or MUGA scan of ≥ 45%, FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin), EKG with no clinically significant arrhythmia, Patients should have New York Heart Association (NYHA) Functional Classification, class -1 or class II, Patients should be evaluated for fitness for HBO by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen, Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen, Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days following completion of therapy
RIC is considered in those older than 45 or younger than 45 with Hematopoietic Cell Transplant (HCT) Comorbidity Index of 3 or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights
HBO-UBC Trial Summary
This trial is testing whether the UCB transplant is more effective than the standard stem cell transplant for treating leukemia.
Who is the study for?
This trial is for adults aged 18-70 with certain blood or lymph gland cancers needing a stem cell transplant but lacking matched donors. They must be in good physical condition, not pregnant, agree to use contraception, and have no severe lung/heart issues or recent surgeries that could complicate treatment.Check my eligibility
What is being tested?
The study tests if hyperbaric oxygen therapy can improve the success of umbilical cord blood stem cell transplants in treating various cancers by reducing complications like graft versus host disease.See study design
What are the potential side effects?
Potential side effects include ear and sinus pressure changes, temporary vision changes, fatigue, and rarely, lung collapse due to increased air pressure experienced during hyperbaric oxygen therapy.
HBO-UBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 45 or under 45 with a high HCT comorbidity index.
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I am between 18 and 70 years old.
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My leukemia is not in the early favorable-risk stage.
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My liver, kidneys, heart, and lungs are healthy enough for a transplant.
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My MDS/MPN shows less than 10% bone marrow blasts and no blood blasts.
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I am able to care for myself but may not be able to do active work.
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My Hodgkin's disease came back after strong treatment.
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I am considered for reduced-intensity conditioning treatment.
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I am eligible for a stem cell transplant but don’t have a matching donor or can't proceed within 8 weeks.
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My ALL is considered high-risk based on specific criteria.
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My non-Hodgkin's lymphoma responded to chemotherapy but returned after a high-dose treatment and stem cell transplant.
HBO-UBC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to neutrophil recovery
Secondary outcome measures
Time to full donor chimerism.
Time to platelet count recovery.
Time to transfusion independency for platelets.
+1 moreOther outcome measures
Percentage of CD34+EPOR+ cells in infused UCB units.
Serum EPO blood levels.
HBO-UBC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HBO armExperimental Treatment1 Intervention
Group II: non-HBO armActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric oxygen
2013
Completed Phase 4
~280
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
837 Previous Clinical Trials
518,053 Total Patients Enrolled
Omar AljitawiPrincipal Investigator - University of Rochester
Strong Memorial Hospital
University Of Jordan (Medical School)
E Tn U-J H Quillen College Medicine (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: HBO arm
- Group 2: non-HBO arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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"
Answered by AI
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."
Answered by AI
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."
Answered by AI
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