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

N/ACompletedNCT02099266

University of Kansas Medical Center15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome (MDS)Hodgkins Lymphoma

Eligibility

Sex: ALLMin age: 17 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Toxicity assessment with 24hrs of treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: 28 days