Acute Myeloid LeukemiaNCT02099266
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
A study testing Administration of hyperbaric oxygen in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University of Kansas Medical Center at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS)
- What is being tested?
- Administration of hyperbaric oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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
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
Read the 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.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome (MDS), Hodgkins Lymphoma, Non-Hodgkins Lymphoma
- Being tested
- Administration of hyperbaric oxygen
- Keywords
- Umbilical Cord Blood (UCB) Stem Cell Transplant, Hyperbaric oxygen, Leukemia, Lymphoma, MDS
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Hodgkin Disease, Lymphoma, Non-Hodgkin, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of hyperbaric oxygenDevice
Also called Monoplace Hyperbaric Chamber Model 3200 and 3200R
Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Treatment | Experimental | Administration of hyperbaric oxygen the morning of UCB transplant. Receives: Device: Administration of hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Toxicity assessment with 24hrs of treatment
Secondary outcomes (2)
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.
Measured: Daily measurement of neutrophil counts up to 90 days post transplant.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar Aljitawi, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099266
- Sponsor's protocol ID
- BMT-2011-08-01
- Status last verified
- May 2017
- First submitted
- 20 Mar 2014
- Last updated
- 12 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27760758
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02099266
- Acronym / sponsor ID
- BMT-2011-08-01
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Posted 17 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Treatment | Experimental | Device: Administration of hyperbaric oxygenAdministration of hyperbaric oxygen the morning of UCB transplant. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy or breast feeding
- Severe chronic obstructive pulmonary disease requiring oxygen supplementation
- History of spontaneous pneumothorax
- History of seizures
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of hyperbaric oxygenAlso: Monoplace Hyperbaric Chamber Model 3200 and 3200RHyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours | Device | Hyperbaric Oxygen Treatment |
Primary outcome
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.
2 secondary outcomes
Determine the Effects of HBO Therapy on Neutrophil Count Recovery.
Time frame: Daily measurement of neutrophil counts up to 90 days post transplant.
Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27760758Aljitawi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Aljitawi, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of hyperbaric oxygen in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation (time frame: Toxicity assessment with 24hrs of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.