What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapeutic agents like daunorubicin and cytarabine. These treatments are associated with side effects such as myelosuppression (leading to increased risk of infections and bleeding), gastrointestinal symptoms (nausea, vomiting, diarrhea), mucositis, and cardiotoxicity, particularly with anthracyclines like daunorubicin. Hyperbaric oxygen therapy (HBOT), which is being studied for its potential benefits in AML, generally has side effects like ear and sinus pain, temporary vision changes, and, in rare cases, oxygen toxicity. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's needs.

What prior FDA approvals exist?

FDA-approved treatments for Acute Myeloid Leukemia (AML) include hypomethylating agents like azacitidine and decitabine, often used in combination with venetoclax or ivosidenib for patients who are not candidates for intensive chemotherapy. These combinations have shown benefits in overall survival and response rates. While hyperbaric oxygen therapy (HBOT) is being studied for its potential to enhance chemotherapy effects by increasing oxygen availability to tissues, it is not yet an FDA-approved treatment for AML.

What other types of research exist?

Promising novel alternatives to Hyperbaric Oxygen Therapy for Acute Myeloid Leukemia patients include combination therapies such as Hypomethylating Agents (HMA) with venetoclax or ivosidenib. These combinations have shown improved outcomes compared to HMA monotherapy. Additionally, the AIR (Low Dose ARA-C, Interferon-Alpha, and Cis-Retinoic Acid) combination therapy has shown potential benefits in poor-risk AML patients, though further evaluation is needed to identify predictive response parameters.

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Hyperbaric Oxygen Therapy for Leukemia

Q: What is the mechanism of action of this treatment?

The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapeutic agents such as cytarabine and anthracyclines (e.g., daunorubicin or idarubicin). These drugs work by interfering with DNA synthesis and inducing apoptosis in rapidly dividing leukemic cells. Cytarabine incorporates into DNA and inhibits DNA polymerase, while anthracyclines intercalate into DNA and generate reactive oxygen species (ROS) that cause DNA damage. Hyperbaric oxygen therapy (HBOT) increases oxygen availability to tissues, potentially enhancing the efficacy of these treatments by improving tissue oxygenation, reducing hypoxia, and promoting better drug delivery. This is particularly important for AML patients as it may enhance the overall effectiveness of chemotherapy and support faster recovery by reducing inflammation and promoting healing.

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)

Must not have

Uncontrolled asthma

Severe chronic obstructive pulmonary disease requiring oxygen supplementation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 100 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if hyperbaric oxygen therapy is safe and effective for patients with certain types of chronic leukemia undergoing stem cell transplantation. The therapy involves breathing pure oxygen in a pressurized chamber to help the body heal and fight infections. Researchers hope it will improve outcomes like the success of the transplant and reduce problems like inflammation and infections. Hyperbaric oxygen therapy has been studied for its potential to improve outcomes in patients undergoing stem cell transplantation by enhancing the success of the transplant and reducing problems.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My asthma is not well-managed.

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I need oxygen therapy for my severe COPD.

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I have had ear surgery, but not for ear tubes.

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I have cancer, but it's not one of the excluded types like AML or CML.

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I do not have any uncontrolled infections.

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I have had a collapsed lung, chest surgery, or radiation to my lungs.

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I haven't had chemotherapy in the spine or brain radiation in the last 2 or 4 weeks, respectively.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 100 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~100 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 100 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Time to complete donor chimerism in Cohort 1

Time to complete donor chimerism in Cohort 2

Time to neutrophil recovery in Cohort 1

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric oxygen

2013

Completed Phase 4

~360

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapeutic agents such as cytarabine and anthracyclines (e.g., daunorubicin or idarubicin). These drugs work by interfering with DNA synthesis and inducing apoptosis in rapidly dividing leukemic cells. Cytarabine incorporates into DNA and inhibits DNA polymerase, while anthracyclines intercalate into DNA and generate reactive oxygen species (ROS) that cause DNA damage. Hyperbaric oxygen therapy (HBOT) increases oxygen availability to tissues, potentially enhancing the efficacy of these treatments by improving tissue oxygenation, reducing hypoxia, and promoting better drug delivery. This is particularly important for AML patients as it may enhance the overall effectiveness of chemotherapy and support faster recovery by reducing inflammation and promoting healing.

Targeting Leukemia Stem Cell-Niche Dynamics: A New Challenge in AML Treatment.Reactive oxygen species in eradicating acute myeloid leukemic stem cells.Protection of acute myeloid leukaemia cells from apoptosis induced by front-line chemotherapeutics is mediated by haem oxygenase-1.