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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of hyperbaric oxygen
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Umbilical Cord Blood (UCB) Stem Cell Transplant, Hyperbaric oxygen, Leukemia, Lymphoma, MDS

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric Oxygen Treatment

Arm Description

Administration of hyperbaric oxygen the morning of UCB transplant.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
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.
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
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.

Full Information

First Posted
March 20, 2014
Last Updated
May 9, 2017
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02099266
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric Oxygen Treatment
Arm Type
Experimental
Arm Description
Administration of hyperbaric oxygen the morning of UCB transplant.
Intervention Type
Device
Intervention Name(s)
Administration of hyperbaric oxygen
Other Intervention Name(s)
Monoplace Hyperbaric Chamber Model 3200 and 3200R
Intervention Description
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Primary Outcome Measure Information:
Title
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation
Description
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.
Time Frame
Toxicity assessment with 24hrs of treatment
Secondary Outcome Measure Information:
Title
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
Description
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.
Time Frame
Daily measurement of neutrophil counts up to 90 days post transplant.
Title
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
Description
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.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Aljitawi, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27760758
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.
Results Reference
derived

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

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