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Acute Myeloid LeukemiaEarly Phase 1NCT03964506

Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant

A Early Phase 1 study testing Hyperbaric oxygen in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Omar Aljitawi at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Hyperbaric oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
1 Jul 2020to 1 Mar 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent
  • Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
  • Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.
  • Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort 2.
  • 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).
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  • Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST < 4x IULN and serum total bilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin)
  • 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.
  • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen

Who cannot join

  • Pregnant or breastfeeding
  • Severe chronic obstructive pulmonary disease requiring oxygen supplementation
  • History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs
  • Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
  • Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS/MPN overlap syndrome.
  • Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist.
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  • Recent sinus surgery (within the last 5 years).
  • Ear surgery excluding myringotomy or ear tubes
  • Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed.
  • Claustrophobia
  • History of recurrent seizures within 5 years of study enrollment.
  • Uncontrolled asthma
  • Uncontrolled viral or bacterial infection at the time of study enrollment
  • Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval
  • Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Regulatory Coordinator contact

(585) 276-7078

Lisa_Metzger@URMC.Rochester.edu

United States1 site, 1 recruiting

  • Wilmot Cancer Institute, University of Rochester

    Rochester, New York, 14642

    Omar Aljitawi

    Lisa Metzger

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem/Progenitor Transplantation

The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth or gut) and infection. This study has two cohorts. The first cohort is subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS). The second cohort is subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), chronic monocytic leukemia, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome. The first cohort has completed the recruitment so only the second cohort will be recruited.

Being tested
Hyperbaric oxygen
Keywords
Allogeneic transplant, Hyperbaric Oxygen
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Leukemia, Myeloid, Primary Myelofibrosis, Myelodysplastic-Myeloproliferative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric oxygenDrug

    Also called HBO

    Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant

Study groups in NCT03964506
Study groupRoleWhat they receive
Cohort 1- AML or MDSExperimentalPatients 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.
Receives: Drug: Hyperbaric oxygen
Cohort 2- CMML, aCML, CML, CNL, MDS/MPNExperimentalPatients 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.
Receives: Drug: Hyperbaric oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1

    Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.

    Measured: 24 hours

  2. Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2

    Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.

    Measured: 24 hours

  3. Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1

    Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant

    Measured: 100 days

  4. Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2

    Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant

    Measured: 100 days

Secondary outcomes (10)

  1. Time to neutrophil recovery in Cohort 1

    based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter

    Measured: 100 days

  2. Time to neutrophil recovery in Cohort 2

    based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter

    Measured: 100 days

  3. Time to complete donor chimerism in Cohort 1

    Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care

    Measured: 100 days

  4. Time to complete donor chimerism in Cohort 2

    Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care

    Measured: 100 days

  5. Incidence of mucositis in Cohort 1

    Measured: 100 days

  6. Incidence of graft versus host disease in Cohort 1

    Measured: 100 days

  7. Incidence of infection in Cohort 1

    Measured: 100 days

  8. Incidence of mucositis in Cohort 2

    Measured: 100 days

  9. Incidence of infection in Cohort 2

    Measured: 100 days

  10. Incidence of graft versus host disease in Cohort 2

    Measured: 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2019
  2. Study start1 Jul 2020
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03964506
Sponsor's protocol ID
UBMT-19163
Status last verified
Jun 2026
First submitted
23 May 2019
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data collected during the trial will be shared after deidentification, including dictionaries.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Hyperbaric oxygen in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Omar Aljitawi 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Regulatory Coordinator ((585) 276-7078, Lisa_Metzger@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1 (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 NCT03964506.

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 3 Jun 2026.

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