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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02099266
Other study ID # BMT-2011-08-01
Secondary ID
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


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
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