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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS), Hodgkins Lymphoma, Non-Hodgkins Lymphoma

Intervention / Treatment
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* Device: Administration of hyperbaric oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary written informed consent Subjects must be >/= 17 yrs and </= 70 yrs for non-myeloablative transplant Subjects must be >/= 17 yrs and </= 55 yrs for myeloablative transplant Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant Use of approved form of contraception Karnofsky performance status of >/= 70% Adequate hepatic, renal, pulmonary and cardiac function. Criteria include: ALT (alanine aminotransferase), AST (aspartate aminotransferase: < 4x IULN (institutional upper limit of normal) Total bilirubin </= 2 mg/dL Serum creatinine < 2.0 mg/dL Left ventricular ejection fraction >/= 45% FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin) Exclusion Criteria: Pregnancy or breast feeding Severe chronic obstructive pulmonary disease requiring oxygen supplementation History of spontaneous pneumothorax History of seizures Claustrophobia Asthma Uncontrolled viral or bacterial infection at the time of enrollment Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric Oxygen Treatment<br>Administration of hyperbaric oxygen the morning of UCB transplant. | Device: Administration of hyperbaric oxygen<br>* Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours<br>* Other names: Monoplace Hyperbaric Chamber Model 3200 and 3200R;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation | 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. | Toxicity assessment with 24hrs of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the Effects of HBO Therapy on Neutrophil Count Recovery. | 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. | Daily measurement of neutrophil counts up to 90 days post transplant. | 
| Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment. | 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. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Umbilical Cord Blood (UCB) Stem Cell Transplant, Hyperbaric oxygen, Lymphoma, MDS