A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem/Progenitor Transplantation
Summary
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.
Arms & interventions
- DrugHyperbaric oxygen
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Outcome measures
Primary
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.
Time frame: 24 hours
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.
Time frame: 24 hours
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
Time frame: 100 days
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 frame: 100 days
Secondary
Time to neutrophil recovery in Cohort 1
Time frame: 100 days
Time to neutrophil recovery in Cohort 2
Time frame: 100 days
Time to complete donor chimerism in Cohort 1
Time frame: 100 days
Time to complete donor chimerism in Cohort 2
Time frame: 100 days
Incidence of mucositis in Cohort 1
Time frame: 100 days
Incidence of graft versus host disease in Cohort 1
Time frame: 100 days
Incidence of infection in Cohort 1
Time frame: 100 days
Incidence of mucositis in Cohort 2
Time frame: 100 days
Incidence of infection in Cohort 2
Time frame: 100 days
Incidence of graft versus host disease in Cohort 2
Time frame: 100 days
Eligibility criteria
Study locations (1)
Wilmot Cancer Institute, University of Rochester
Rochester, New York, 14642