← Back to Search

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
Subjects must be ≥ 18 years old and ≤ 70 years old
Must not have
History of spontaneous pneumothorax
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
My leukemia is not in the early favorable-risk stage.
Select...
My liver, kidneys, heart, and lungs are healthy enough for a transplant.
Select...
My MDS/MPN shows less than 10% bone marrow blasts and no blood blasts.
Select...
I am able to care for myself but may not be able to do active work.
Select...
My Hodgkin's disease came back after strong treatment.
Select...
My non-Hodgkin's lymphoma responded to chemotherapy but returned after a high-dose treatment and stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a collapsed lung without injury.
Select...
I need oxygen therapy for my severe COPD.
Select...
I haven't had chemotherapy in the spine or brain radiation within the last month.
Select...
I currently have an ear or sinus infection.
Select...
I have had surgery or radiation therapy directly on my chest before.
Select...
I have a history of seizures.
Select...
I have not had sinus or ear surgery, except for ear tubes, in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~360

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
869 Previous Clinical Trials
549,698 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

Hyperbaric oxygen Clinical Trial Eligibility Overview. Trial Name: NCT03739502 — Phase 2
Myelodysplastic Syndrome Research Study Groups: HBO arm, non-HBO arm
Myelodysplastic Syndrome Clinical Trial 2023: Hyperbaric oxygen Highlights & Side Effects. Trial Name: NCT03739502 — Phase 2
Hyperbaric oxygen 2023 Treatment Timeline for Medical Study. Trial Name: NCT03739502 — Phase 2
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top