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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT02099266
First received: March 20, 2014
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome (MDS)
Hodgkins Lymphoma
Non-Hodgkins Lymphoma
Device: Administration of hyperbaric oxygen

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Safety of HBO administration in the setting of UCB stem cell transplantation [ Time Frame: Toxicity assessment with 24hrs of treatment ] [ Designated as safety issue: Yes ]
    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:
  • Determine the effects of HBO therapy on neutrophil count recovery. [ Time Frame: Daily measurement of neutrophil counts up to 90 days post transplant. ] [ Designated as safety issue: No ]
    Subjects will be followed daily until neutrophil recovery, defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.

  • Determine the effects of HBO therapy on engraftment [ Time Frame: Bone marrow chimerism testing at Day 21 or Day 28 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • To explore the effects of HBO therapy on inflammatory cytokines and EPO levels [ Time Frame: Blood sample collection Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO. ] [ Designated as safety issue: No ]
    Determine if inflammatory cytokine and EPO levels are dropping after the HBO treatment

  • Determine the correlation between change in EPO levels and time to neutrophil recovery and engraftment. [ Time Frame: EPO measurements: Pre-HBO (Day 0), 6hrs, 8hrs, 24hrs, 48hrs post HBO. ] [ Designated as safety issue: No ]
    Erythropoietin blood levels will be correlated to the daily neutrophil counts to assess any relationship between EPO levels and subsequent engraftment and neutrophil recovery.


Estimated Enrollment: 10
Study Start Date: June 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntary written informed consent
  • Subjects must be >/= 18 yrs and </= 70 yrs for non-myeloablative transplant
  • Subjects must be >/= 18 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02099266

Contacts
Contact: Omar Aljitawi, MD 913-588-6029 oaljitawi@kumc.edu
Contact: Kelly Daniels 913-945-6591 kdaniels2@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Omar Aljitawi, MD    913-588-6029    oaljitawi@Kumc.edu   
Contact: Kelly Daniels    913-945-6591    kdaniels2@kumc.edu   
Principal Investigator: Omar Aljitawi, MD         
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Omar Aljitawi, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT02099266     History of Changes
Other Study ID Numbers: BMT-2011-08-01
Study First Received: March 20, 2014
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Umbilical Cord Blood (UCB) Stem Cell Transplant
Hyperbaric oxygen
Leukemia
Lymphoma
MDS

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 22, 2014