Actively Recruiting
Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
Led by Omar Aljitawi · Updated on 2025-04-04
24
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth or gut) and infection. This study has two cohorts. The first cohort is subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS). The second cohort is subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), chronic monocytic leukemia, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome. The first cohort has completed the recruitment so only the second cohort will be recruited.
CONDITIONS
Official Title
Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent
- Men or women aged 18 to 75 years
- Diagnosis of chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, chronic monocytic leukemia, chronic neutrophilic leukemia, myelofibrosis, or myelodysplastic/myeloproliferative overlap syndrome (cohort 2)
- Karnofsky performance status of 70% or higher
- New York Heart Association Functional Class I or II
- Adequate liver function: ALT and AST less than 4 times the upper limit of normal, and total bilirubin 2.0 mg/dL or less
- Adequate kidney function: serum creatinine 2.0 mg/dL or less
- Heart function: left ventricular ejection fraction 45% or higher by 2D-ECHO or MUGA scan
- No clinically significant arrhythmia on EKG
- Lung function: FEV1, FVC, and DLCO 50% or higher of predicted (corrected for hemoglobin)
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use effective contraception during and for 30 days after the study
- Women of child-bearing potential must have a negative pregnancy test within 4 weeks before starting preparative treatment
You will not qualify if you...
- Pregnant or breastfeeding
- Severe chronic obstructive pulmonary disease requiring oxygen
- History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy, or direct chest radiation to the lungs
- Pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days before transplant
- Active malignancy other than specified leukemias and syndromes
- Active ear or sinus infection, chronic sinusitis or sinus headaches unless cleared by a specialist
- Sinus surgery in the past 5 years
- Ear surgery other than myringotomy or ear tubes
- Use of tobacco or e-cigarettes within 72 hours before transplant until full recovery (nicotine replacement allowed)
- Claustrophobia
- History of recurrent seizures within 5 years
- Uncontrolled asthma
- Uncontrolled viral or bacterial infection at enrollment
- Active or recent invasive fungal infection without specialist approval
- Intrathecal chemotherapy within 2 weeks or cranial irradiation within 4 weeks before preparative treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wilmot Cancer Institute, University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
Research Team
R
Regulatory Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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