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Hyperbaric Oxygen Therapy for Leukemia
Phase < 1
Recruiting
Led By Omar S Aljitawi, MBBS
Research Sponsored by Omar Aljitawi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (KPS) of ≥ 70%
Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days
Awards & highlights
Study Summary
This trial is testing if hyperbaric oxygen therapy is safe for people with different types of leukemia who are having stem cell transplants. They will also test if it helps with side effects like mouth and gut inflammation, infection, and low blood cell counts.
Who is the study for?
Adults aged 18-75 with certain blood disorders like chronic myelomonocytic leukemia and myelofibrosis, who are fit enough for a stem cell transplant. They must have good heart, liver, kidney, and lung function and agree to use contraception. People with active infections or other cancers, recent ear/sinus issues or surgeries, severe asthma or COPD requiring oxygen can't join.Check my eligibility
What is being tested?
The trial is testing if hyperbaric oxygen therapy is safe during stem cell transplants and if it helps with graft success, reduces mouth/gut inflammation (mucositis), infection rates, and improves white blood cell counts in patients with specific types of leukemia or myelodysplastic syndromes.See study design
What are the potential side effects?
Potential side effects may include discomfort due to high oxygen levels such as ear pressure or sinus pain. There's also a risk of lung injury from increased air pressure but the study aims to confirm safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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My heart condition does not severely limit my daily activities.
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I am between 18 and 75 years old.
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I have a specific type of blood cancer such as CMML, aCML, CML, CNL, myelofibrosis, or MDS/MPN overlap syndrome.
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I have AML or MDS and am interested in joining cohort 1.
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I am between 18 and 75 years old.
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I have been diagnosed with AML or MDS.
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My heart condition does not severely limit my daily activities.
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My liver, kidney, heart, and lung functions meet the required levels for a transplant.
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I have a specific type of blood cancer such as CMML, aCML, CML, CNL, myelofibrosis, or MDS/MPN overlap syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2
Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1
+1 moreSecondary outcome measures
Incidence of graft versus host disease in Cohort 1
Incidence of graft versus host disease in Cohort 2
Incidence of infection in Cohort 1
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2- CMML, aCML, CML, CNL, MDS/MPNExperimental Treatment1 Intervention
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
Group II: Cohort 1- AML or MDSExperimental Treatment1 Intervention
Patients with will receive HBO therapy one time on day 0 of the transplant. The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber (Model 3200/3200R, Sechrist Industries, Inc., USA), breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes were spent during the compression and decompression phases and subjects had 10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric oxygen
2013
Completed Phase 4
~280
Find a Location
Who is running the clinical trial?
Omar AljitawiLead Sponsor
1 Previous Clinical Trials
99 Total Patients Enrolled
Omar S Aljitawi, MBBSPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My asthma is not well-managed.I have had a fungal infection in the past 6 months without approval from a specialist.I need oxygen therapy for my severe COPD.I am able to care for myself but may not be able to do active work.I had sinus surgery in the last 5 years.I am between 18 and 75 years old.I have had a collapsed lung or significant lung scarring seen on imaging within the last 2 months.I do not have any uncontrolled infections.I am a woman who can have children and have a negative pregnancy test.I have had a collapsed lung, chest surgery, or radiation to my lungs.I have a specific type of blood cancer such as CMML, aCML, CML, CNL, myelofibrosis, or MDS/MPN overlap syndrome.I have AML or MDS and am interested in joining cohort 1.I am a woman who can still have children and have not been through menopause.I have cancer, but it's not one of the excluded types like AML or CML.I have had ear surgery, but not for ear tubes.My heart condition does not severely limit my daily activities.I agree to use effective birth control during and for 30 days after the study.I haven't had chemotherapy in the spine or brain radiation in the last 2 or 4 weeks, respectively.I agree to not use tobacco or e-cigarettes 72 hours before my transplant until I have fully recovered.My heart condition does not severely limit my daily activities.My liver, kidney, heart, and lung functions meet the required levels for a transplant.I am between 18 and 75 years old.I have been diagnosed with AML or MDS.I do not have an active ear or sinus infection, or if I have chronic issues, I've been cleared by a specialist.I have had seizures in the last 5 years.I have a specific type of blood cancer such as CMML, aCML, CML, CNL, myelofibrosis, or MDS/MPN overlap syndrome.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1- AML or MDS
- Group 2: Cohort 2- CMML, aCML, CML, CNL, MDS/MPN
Acute Myeloid Leukemia Patient Testimony for trial: Trial Name: NCT03964506 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of people taking part in this clinical trial?
"Affirmative. Per the clinicaltrials.gov database, this experiment is currently accepting applications; it was initially launched on July 1st 2020 and its most recent update arrived on May 16th 2021. It needs to recruit 24 participants from a single research centre."
Answered by AI
Does the trial accept participants of a certain age limit, such as those under 25?
"As specified by the formal requirements, only patients aged between 18 and 75 may participate in this trial. For those below 18 years old or above 65, there are 464 studies and 1425 studies respectively."
Answered by AI
Is this research study presently recruiting participants?
"Affirmative, according to information on clinicaltrials.gov this medical trial is taking in patients as of now. It was initially posted on July 1st 2020 and edited most recently on May 16th 2022; the research team aims to enrol 24 individuals at a single location."
Answered by AI
Are there any eligibility requirements I must meet to take part in this experimental research?
"This clinical trial is recruiting 24 individuals aged 18-75 affected by myelodysplastic syndromes. Eligibility criteria include voluntary written consent, Karnofsky performance status of 70% or higher, left ventricular ejection fraction of 45%, New york Heart Association (NYHA) Functional Classification Class I/II and adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Additionally, women with childbearing potential must agree to use appropriate contraception during the duration of study participation and 30 days post therapy; any woman who suspects pregnancy while enrolled in this study should report it immediately to her treating physician and investigator"
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
New Jersey
Missouri
Other
How old are they?
65+
What site did they apply to?
Wilmot Cancer Institute, University of Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
Procrit and now started Luspatercept.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
What does “Informed Consent “ mean?
PatientReceived no prior treatments
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