Clinical trial NCT02099266: Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome (MDS)
Hodgkins Lymphoma
Non-Hodgkins Lymphoma
Keywords: Umbilical Cord Blood (UCB) Stem Cell Transplant
Hyperbaric oxygen
Leukemia
Lymphoma
MDS
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 15
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
timeFrame: Toxicity assessment with 24hrs of treatment
Secondary outcomes:
measure: Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
timeFrame: Daily measurement of neutrophil counts up to 90 days post transplant.
measure: Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
timeFrame: 28 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Omar Aljitawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aljitawi OS, Paul S, Ganguly A, Lin TL, Ganguly S, Vielhauer G, Capitano ML, Cantilena A, Lipe B, Mahnken JD, Wise A, Berry A, Singh AK, Shune L, Lominska C, Abhyankar S, Allin D, Laughlin M, McGuirk JP, Broxmeyer HE. Erythropoietin modulation is associated with improved homing and engraftment after umbilical cord blood transplantation. Blood. 2016 Dec 22;128(25):3000-3010. doi: 10.1182/blood-2016-05-715292. Epub 2016 Oct 19.