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

University of Kansas Medical Center1 site in 1 country15 target enrollmentJune 2013

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: University of Kansas Medical Center
Enrollment: 15
Locations: 1
Primary Endpoint: Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

February 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Kansas Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•Pregnancy or breast feeding
•Severe chronic obstructive pulmonary disease requiring oxygen supplementation
•History of spontaneous pneumothorax
•History of seizures
•Claustrophobia
•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

Time Frame: Toxicity assessment with 24hrs of treatment

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.

Secondary Outcomes

Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.(28 days)
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.(Daily measurement of neutrophil counts up to 90 days post transplant.)