Hyperbaric Oxygen Therapy for Leukemia

Overseen By Regulatory Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Omar Aljitawi

Disqualifiers: Pregnancy, COPD, Pneumothorax, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of hyperbaric oxygen therapy for patients undergoing stem cell transplants for certain types of leukemia. The therapy involves breathing pure oxygen in a pressurized chamber to address complications such as engraftment, infections, and mouth or gut inflammation. The trial seeks participants with specific types of chronic leukemia, such as chronic myelomonocytic leukemia (CMML) and similar conditions. Suitable candidates have these types of leukemia and meet specific health criteria, including manageable heart and lung function. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your medications with the study team to ensure they don't interfere with the trial.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hyperbaric oxygen therapy is safe for stem cell transplantation?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally well-tolerated. In one study with 49 patients, most of whom had acute myeloid leukemia, HBOT did not cause severe side effects.

The treatment involves breathing pure oxygen in a pressurized room or chamber, which increases oxygen levels in the blood to support healing and fight infection. Some patients might experience mild side effects like ear pressure or tiredness, but serious problems are rare.

This trial is in the early stages, so information on its safety for this specific use is limited. However, HBOT is already used for other medical conditions, suggesting it is reasonably safe. Participants should discuss any concerns with their healthcare provider before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about hyperbaric oxygen therapy for leukemia because it offers a novel approach compared to standard treatments like chemotherapy and radiation. This therapy involves breathing pure oxygen in a hyperbaric chamber, which can potentially improve oxygen delivery to tissues and boost healing. Unlike traditional treatments that primarily target cancer cells directly, hyperbaric oxygen therapy may enhance the body's natural ability to repair and regenerate after a bone marrow transplant. This unique mechanism of enhancing tissue oxygenation could be a game-changer in supporting recovery and improving outcomes for leukemia patients.

What evidence suggests that hyperbaric oxygen therapy might be an effective treatment for leukemia?

Research shows that hyperbaric oxygen therapy, which involves breathing pure oxygen in a pressurized room, is under study in this trial to assist patients with various types of leukemia during stem cell transplants. Participants in Cohort 1, including those with AML or MDS, and Cohort 2, including those with CMML, aCML, CML, CNL, and MDS/MPN, will receive this therapy. This treatment might enhance the engraftment process, where new stem cells settle into the body. It could also help reduce common post-transplant issues, such as graft versus host disease and infections. Although still in early stages, studies suggest that this therapy might improve outcomes by aiding immune system recovery. However, the exact effectiveness for the specific conditions in this trial remains under evaluation. ^{1 2 3 6 7}

Who Is on the Research Team?

Omar S Aljitawi, MBBS

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

Claustrophobia

My asthma is not well-managed.

I have had a fungal infection in the past 6 months without approval from a specialist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperbaric oxygen therapy on day 0 of the transplant, involving exposure to 2.5 ATA for 90 minutes in a hyperbaric chamber

1 day

1 visit (in-person)

Immediate Safety Assessment

Treatment-limiting toxicities are assessed 24 hours post-hyperbaric oxygen therapy

1 day

Follow-up

Participants are monitored for safety and effectiveness, including neutrophil recovery and donor chimerism, up to 100 days post-transplant

100 days

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric oxygen

Trial Overview

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.

How Is the Trial Designed?

Group I: Cohort 2- CMML, aCML, CML, CNL, MDS/MPN Experimental Treatment 1 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 MDS Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Omar Aljitawi

Lead Sponsor

Trials

2

Recruited

120+

Published Research Related to This Trial

The author highlights significant advancements in leukemia therapy over their career, suggesting that these breakthroughs will continue to influence future cancer treatments.

Discoveries in leukemia biology and treatment are expected to play a crucial role in developing therapies for solid tumors, indicating a promising direction for overall cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The history of leukemia therapy--a personal journey. Freireich, EJ.[2012]

In a study of 1,308 patients receiving hyperbaric oxygen (HBO2) therapy, five seizure episodes were reported during 10,425 treatments, indicating a low but notable risk of seizures, particularly in patients with carbon monoxide poisoning and arterial gas embolism.

Despite the occurrence of seizures, none of the patients experienced lasting effects, suggesting that while seizures can happen during HBO2 therapy, the overall safety profile remains high, and clinicians should be prepared to manage such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. Lee, CH., Choi, JG., Lee, JS., et al.[2021]

Recent advances in leukemia treatment have been driven by a better understanding of genetic mutations and biochemical pathways, allowing for more targeted therapies tailored to individual patients.

New therapies, including the use of recombinant urate oxidase (rasburicase) to manage complications like tumor lysis syndrome, highlight the progress made in designing effective treatments based on molecular biology and biotechnology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment by design in leukemia, a meeting report, Philadelphia, Pennsylvania, December 2002. Larson, RA., Daley, GQ., Schiffer, CA., et al.[2018]

In a study of 495 pediatric patients with acute lymphoblastic leukemia (ALL), 4.6% developed osteonecrosis (ON), with higher risks associated with older age and increased steroid dosage.

Hyperbaric oxygen therapy (HBO) was used in 8 patients with ON, and during follow-up, 15 out of 23 patients showed stability in their condition, indicating that early diagnosis and conservative treatments like HBO may improve outcomes for ON in ALL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteonecrosis in Children and Adolescents With Acute Lymphoblastic Leukemia: Early Diagnosis and New Treatment Strategies. Biddeci, G., Bosco, G., Varotto, E., et al.[2019]

Bone marrow transplantation (BMT) has significantly improved as a treatment for leukemia, with a high survival rate of 76% when performed during the first remission of acute lymphoblastic leukemia.

The timing of BMT is crucial for patient outcomes, as survival rates are higher in earlier disease stages, indicating that early intervention can lead to better chances of complete cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bone marrow transplantation after intensive chemotherapy]. Masaoka, T.[2013]

In a five-year study of 2,610 patients undergoing hyperbaric oxygen therapy (HBO2), 10.04% experienced middle ear barotrauma (MEB), highlighting it as a common side effect that can lead to premature treatment discontinuation.

Risk factors for MEB included being over 55 years old, female gender, and having a history of ear, nose, and throat issues, suggesting that identifying and managing these factors could help reduce the incidence of this adverse event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle-ear barotrauma after hyperbaric oxygen therapy: a five-year retrospective analysis on 2,610 patients. Edinguele, WFOP., Barberon, B., Poussard, J., et al.[2021]

Differentiation therapy for leukemia, particularly successful in acute promyelocytic leukemia with all-trans-retinoic acid, represents a targeted treatment approach that induces cancer cell maturation rather than killing them directly.

Recent laboratory studies have shown that various hematopoietic cytokines can promote specific differentiation of leukemia cells, suggesting that understanding these mechanisms could enhance future clinical treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytokines in the differentiation therapy of leukemia: from laboratory investigations to clinical applications. Leung, KN., Mak, NK., Fung, MC.[2019]

As leukemia treatments improve, patients are living longer, making it crucial to quickly identify and manage neurological complications that can arise from the disease or its treatments.

Recent advancements in diagnosing and treating neurological issues related to leukemia, such as central nervous system prophylaxis and leptomeningeal metastasis, are essential for improving patient outcomes and reducing long-term health problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic complications of leukemia. Demopoulos, A., DeAngelis, LM.[2013]

Intermittent corticosteroid administration can help prevent osteonecrosis in pediatric patients with acute lymphoblastic leukemia, as shown in a randomized controlled trial.

There is a lack of high-quality evidence regarding the treatment of osteonecrosis once it occurs, with most studies on non-surgical and surgical interventions being insufficient to draw clear conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management and treatment of osteonecrosis in children and adolescents with acute lymphoblastic leukemia. Te Winkel, ML., Pieters, R., Wind, EJ., et al.[2021]

In a study involving 31 rats, hyperbaric oxygen therapy (HBOT) at 2 ATA for up to 10 days did not result in significant renal damage or impairment, suggesting that HBOT is safe for renal function in healthy subjects.

The research indicates that HBOT does not adversely affect renal function, as there were no significant changes in renal function tests or histopathological evaluations, supporting its safety profile in healthy rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of hyperbaric oxygen therapy on kidneys in a rat model. Berkovitch, M., Tsadik, R., Kozer, E., et al.[2022]

In a study of 2,334 patients undergoing hyperbaric oxygen (HBO2) therapy, 17.4% experienced adverse events, with the most common being middle ear barotrauma affecting 9.2% of patients.

Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 therapy is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. hadanny, A., Meir, O., Bechor, Y., et al.[2016]

Hyperbaric oxygen therapy (HBOT) is associated with a higher incidence of adverse effects (30.11%) compared to control groups (10.43%), particularly when the treatment involves more than 10 sessions or chamber pressures exceed 2.0 ATA.

The most common side effect reported was ear discomfort, indicating that while HBOT can be beneficial, careful monitoring for adverse reactions is necessary, especially under specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. Zhang, Y., Zhou, Y., Jia, Y., et al.[2023]

Bone marrow transplants, especially from HLA-identical siblings, have shown success in treating leukemia, leading to long-term leukemia-free survival (LFS) rates.

The studies highlight the importance of factors like Graft-versus-Leukemia (GVL) effects in improving treatment outcomes, and both allogeneic and autologous transplants are being explored as effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow transplantation in leukemia. Rowlings, PA., Gale, RP., Horowitz, MM., et al.[2007]

Recent advancements in leukemia treatments have led to high cure rates, such as over 90% for hairy cell leukemia with cladribine and rituximab, and 80-90% for acute promyelocytic leukemia using all-trans retinoic acid and arsenic trioxide.

Chronic lymphocytic leukemia, once considered incurable, may now be potentially curable with targeted therapies like Bruton tyrosine kinase inhibitors and venetoclax, showcasing the significant progress in leukemia treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cure of leukemia through the optimist's prism. Kantarjian, HM., Jain, N., Garcia-Manero, G., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9431014/

P1590: OUTCOME OF HYPERBARIC OXYGEN THERAPY ...

Results: 49 patients were included. Median age at HBO therapy was 51 years (range 22-86). Most common underlying disease was acute myeloid leukemia (53%), ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03964506

Hyperbaric Oxygen Therapy and Allogeneic Peripheral ...

This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of ...

3.

clinical-lymphoma-myeloma-leukemia.com

clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(21)01734-1/pdf

AML-410: Efficacy of Hyperbaric Oxygen Therapy in ...

Results: A total of 50 patients were included: 26 (52%) patients had. Acute Myeloid Leukemia, 31 (62%) patients had received an SCT, and 34 (68%) patients ...

4.

withpower.com

withpower.com/trial/early-phase-1-myelodysplastic-syndromes-6-2020-d5d7f

Hyperbaric Oxygen Therapy for Leukemia

This trial is testing if hyperbaric oxygen therapy is safe and effective for patients with certain types of chronic leukemia undergoing stem cell ...

5.

ctv.veeva.com

ctv.veeva.com/study/hyperbaric-oxygen-therapy-and-allogeneic-peripheral-blood-stem-cell-pbsc-transplant

Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood ...

The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation.

6.

clinicaltrial.be

clinicaltrial.be/en/details/63477?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Hyperbaric Oxygen Therapy and Allogeneic Peripheral ...

The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8465921/

A General Overview on the Hyperbaric Oxygen Therapy

On the other hand, recent data indicates that less cases appears to be treated by HBOT probably by the lack of belief of some physicians in HBOT, particularly ...