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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02099266
• Other study ID #: BMT-2011-08-01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 20, 2014
• Last updated: March 31, 2015
• Start date: June 2013
• Est. completion date: March 2016

Study information

• Verified date: February 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Hodgkin Disease
• Hodgkins Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Non-Hodgkin
• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Non-Hodgkins Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Device:
• Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore the effects of HBO therapy on inflammatory cytokines and EPO levels	Determine if inflammatory cytokine and EPO levels are dropping after the HBO treatment	Blood sample collection Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO.	No
Other	Determine the correlation between change in EPO levels and time to neutrophil recovery and engraftment.	Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between EPO levels and subsequent engraftment and neutrophil recovery.	EPO measurements: Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO.	No
Primary	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	Yes
Secondary	Determine the effects of HBO therapy on neutrophil count recovery.	Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.	Daily measurement of neutrophil counts up to 90 days post transplant.	No
Secondary	Determine the effects of HBO therapy on engraftment	The degree of engraftment will be determined through bone marrow chimerism assessments at either 21 or 28 days. Partial engraftment is defined as marrow reconstitution of 10-90% or donor cells and complete engraftment is defined as greater that 90% of donor cells.	Bone marrow chimerism testing at Day 21 or Day 28	No