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Recruiting EARLY_Phase 1 NCT03964506

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

Trial Parameters

Condition Acute Myeloid Leukemia
Sponsor Omar Aljitawi
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2020-07-01
Completion 2026-03-01
Interventions
Hyperbaric oxygen

Brief 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 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.

Eligibility Criteria

Inclusion Criteria: * 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:

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