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Administration of hyperbaric oxygen the morning of UCB transplant.

Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Administration of hyperbaric oxygen

Omar Aljitawi, MD

By doing this study, researchers hope to learn the following:

* If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process
* The safety of HBO administration in the setting of the UBC transplant
* The effects of HBO therapy on the engraftment process

Research has suggested that high levels of erythropoietin (EPO) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. The investigators will investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.

Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

A Pilot Study to Determine the Safety and Efficacy of Using Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.

Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level \>/= 500 u/L.

Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.

University of Kansas Medical Center

Administration of hyperbaric oxygen the morning of UCB transplant.

Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Hyperbaric Oxygen Treatment

Age, Categorical

Sex: Female, Male

Dr. Omar Aljitawi

grade IV leukopenia

grade III/IV neutropenia

grade III/IV anemia

grade III/IV thrombocytopenia

One patient treatment was shortened by approximately 10 minutes because of nausea attributed to concomitant medications.

Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation

Reduced-Intensity (also referred to as: "Non-myeloablative") transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:

Day -6 : fludarabine 40mg/m2 (milligram per meter squared) intravenously (IV), cyclophosphamide 50mg/kg IV, and mesna 50mg/kg IV Day-5 to -2: fludarabine 40mg/m2 intravenously (IV) Day -1: Total body irradiation (TBI) 200 centrigray (cGy)

Reduced-Intensity Conditioning

Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:

Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV

Myeloablative Conditioning

Determine the Effects of HBO Therapy on Neutrophil Count Recovery.

Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.

Overall Study

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Administration of hyperbaric oxygen on the morning of stem cell transplant (Day 0).

By doing this study, researchers hope to learn the following:

* The safety of hyperbaric oxygen administration in the setting of the autologous transplant
* The effects of hyperbaric oxygen administration on neutrophil count recovery and engraftment

The post stem cell transplant complications of neutropenic fever and mucositis, related to the chemotherapy and/or radiation on hematopoietic tissue administered prior to peripheral blood stem cell transplant, are reversible upon neutrophil count recovery. The investigators will investigate the use of hyperbaric oxygen as an intervention to shorten neutropenia post-high-dose chemotherapy and autologous peripheral blood stem cell transplant. The idea of using hyperbaric oxygen therapy in autologous stem cell transplantation is based on the investigators pre-clinical work that supported the use of hyperbaric oxygen to improve umbilical cord blood (cluster of differentiation 34) CD34+ stem cell transplantation.

Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation

Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplant

Statistical methods will be applied to determine if the mean erythropoietin levels during the first 24 hours and 48 hours correlate with time to neutrophil recovery and engraftment.

Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between erythropoietin levels and subsequent engraftment and neutrophil recovery.

Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: seizure disorder, pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be at least likely related to HBO therapy.

Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil count of \> 500/mm3. If subjects do not exhibit neutrophil recovery by Day 40 post transplant, they will be considered primary graft failures.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment	NCT02099266	Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Hodgkins Lympho... Non-Hodgkins Ly...	Administration ...	17 Years - 70 Years	University of Kansas Medical Center
Pilot Study Exploring the Use of Hyperbaric Oxygen in Autologous Peripheral Blood Stem Cell Transplantation	NCT02087657	Multiple Myelom... Hodgkin's Disea... Non-Hodgkin's L...	Administration ...	18 Years - 70 Years	University of Kansas Medical Center

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