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.
Voluntary written informed consent
Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.
Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort 2.
Pregnant or breastfeeding
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs
Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
Parallel
Hyperbaric oxygen
DrugReduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2
Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2
Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant
Time to neutrophil recovery in Cohort 1
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time to neutrophil recovery in Cohort 2
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time to complete donor chimerism in Cohort 1
Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care
Time to complete donor chimerism in Cohort 2
Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care
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Omar Aljitawi
Lead sponsor
University of Rochester
Sponsor institution
