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Hyperbaric Oxygen Therapy with Stem Cell Transplant for Blood Cancers

This study is looking at whether hyperbaric oxygen therapy (breathing pure oxygen in a special chamber) is safe when given before an allogeneic (from a donor) peripheral blood stem cell (PBSC) transplant. It also aims to see if this therapy can improve how well the transplant works, reduce complications like graft-versus-host disease (when donor cells attack your body), and lessen mouth sores (mucositis) or infections. We are studying this in people aged 18 to 75 who have certain blood cancers like acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML). The study will enroll 24 participants and is currently unclear if it's open for new participants.

Study design
This interventional study plans to enroll 24 participants across two groups with different blood cancers. The study is investigating the safety and effectiveness of hyperbaric oxygen therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will check for long-term safety of hyperbaric oxygen therapy for up to 100 days after the transplant in one group of participants.

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NCT03964506

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

Recruiting
EARLY_PHASE1Ages 18–75InterventionalTreatment
Omar Aljitawi
~24 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Hyperbaric oxygen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1
Measured over 24 hours
+3 more outcomes measured

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia
Chronic Monocytic Leukemia
Myelofibrosis
Myelodysplastic/Myeloproliferative Neoplasm

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Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Omar S Aljitawi, MBBS · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Regulatory Coordinator
[email protected]
(585) 276-7078
Email the study team

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Eligibility criteria

Inclusion

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).
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

Exclusion

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.
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

What this trial measures

  • Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 124 hours

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

  • Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 224 hours

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

  • Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1100 days

    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

  • Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2100 days

    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