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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02099266
Recruitment Status : Completed
First Posted : March 28, 2014
Results First Posted : March 17, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome (MDS) Hodgkins Lymphoma Non-Hodgkins Lymphoma Device: Administration of hyperbaric oxygen Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyperbaric Oxygen Treatment
Administration of hyperbaric oxygen the morning of UCB transplant.
 Device: Administration of hyperbaric oxygen
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Other Name: Monoplace Hyperbaric Chamber Model 3200 and 3200R


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Determine the Effects of HBO Therapy on Neutrophil Count Recovery. [ Time Frame: Daily measurement of neutrophil counts up to 90 days post transplant. ]
    Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.

  2. Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment. [ Time Frame: 28 days ]
    Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099266


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Omar Aljitawi, MD University of Kansas Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02099266    
Other Study ID Numbers: BMT-2011-08-01
First Posted: March 28, 2014    Key Record Dates
Results First Posted: March 17, 2017
Last Update Posted: June 12, 2017
Last Verified: May 2017
Keywords provided by University of Kansas Medical Center:
Umbilical Cord Blood (UCB) Stem Cell Transplant
Hyperbaric oxygen
Leukemia
Lymphoma
MDS
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Preleukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Lymphoid