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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Wilmot Cancer Institute, University of Rochester
Rochester, New York, United States
RECRUITINGImmediate 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
Time to neutrophil recovery in Cohort 1
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time frame: 100 days
Time to neutrophil recovery in Cohort 2
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Time frame: 100 days
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 frame: 100 days
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.