Overview

This trial is active, not recruiting.

Conditions acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome (mds), hodgkins lymphoma, non-hodgkins lymphoma
Treatment administration of hyperbaric oxygen
Sponsor University of Kansas
Start date June 2013
End date September 2015
Trial size 15 participants
Trial identifier NCT02099266, BMT-2011-08-01

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Administration of hyperbaric oxygen the morning of UCB transplant.
administration of hyperbaric oxygen Monoplace Hyperbaric Chamber Model 3200 and 3200R
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Primary Outcomes

Measure
Safety of HBO administration in the setting of UCB stem cell transplantation
time frame: Toxicity assessment with 24hrs of treatment

Secondary Outcomes

Measure
Determine the effects of HBO therapy on neutrophil count recovery.
time frame: Daily measurement of neutrophil counts up to 90 days post transplant.
Determine the effects of HBO therapy on engraftment
time frame: Bone marrow chimerism testing at Day 21 or Day 28

Eligibility Criteria

Male or female participants from 17 years up to 70 years old.

Inclusion Criteria: - Voluntary written informed consent - Subjects must be >/= 17 yrs and /= 17 yrs and /= 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 /= 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

Additional Information

Official title 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
Principal investigator Omar Aljitawi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Kansas.