Actively Recruiting
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
Led by University of Rochester · Updated on 2025-07-08
64
Participants Needed
1
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).
CONDITIONS
Official Title
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent
- Considered for allogeneic transplantation based on disease risk but lack matched sibling or unrelated donors or unable to proceed to transplant within 8 weeks
- Only patients eligible for reduced intensity conditioning (RIC), typically older than 45 or younger with comorbidity index of 3 or higher
- Diagnosed with specific blood cancers: AML in CR1 (non-favorable risk), AML in CR2 or later, high-risk ALL in CR1 or CR2+, biphenotypic or undifferentiated leukemia in CR1 or higher
- MDS/MPN patients with less than 10% bone marrow blasts and no peripheral blood blasts
- Chemotherapy sensitive Hodgkin's disease or non-Hodgkin's lymphoma relapsed after high-dose therapy and autologous transplant
- High-risk features for ALL as defined by specific criteria including high white blood cell count, cytogenetic abnormalities, immunophenotype, delayed remission, age, or MRD level
- Age 18 to 70 years
- Karnofsky performance status of 70% or higher
- Adequate liver, kidney, heart, and lung function meeting defined laboratory and test thresholds
- NYHA class I or II heart function
- Fitness for hyperbaric oxygen therapy confirmed by trained medical professional
- Women of child-bearing potential must have negative pregnancy test within 4 weeks before preparative regimen
- Agreement to use adequate contraception during study and for 30 days after
- Women of child-bearing potential defined by absence of hysterectomy, bilateral oophorectomy, or natural menopause for 12 months
You will not qualify if you...
- Pregnant or breastfeeding
- Severe chronic obstructive pulmonary disease requiring oxygen
- History of spontaneous pneumothorax
- Active ear or sinus infection unless cleared by ENT specialist
- Pneumothorax or significant lung fibrosis on chest imaging within 60 days
- Prior chest surgery requiring thoracotomy or chest irradiation
- Recent sinus or ear surgery (except myringotomy or ear tubes) within last 5 years
- Claustrophobia
- Intrathecal chemotherapy within 2 weeks or cranial irradiation within 4 weeks of preparative regimen
- History of seizures
- Active tobacco use within 72 hours prior to transplant until full recovery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
K
Kaitlyn Burrows
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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