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OncoMatch/Clinical Trials/NCT03964506

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

Is NCT03964506 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Hyperbaric oxygen for acute myeloid leukemia.

Early Phase 1RecruitingOmar AljitawiNCT03964506Data as of May 2026

Treatment: Hyperbaric oxygenThe 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Chronic Myeloid Leukemia

Myeloproliferative Neoplasm

Prior therapy

Cannot have received: intrathecal chemotherapy

Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen

Cannot have received: cranial irradiation

cranial irradiation within 4 weeks of starting preparative regimen

Lab requirements

Kidney function

serum creatinine:  2.0 mg/dL

Liver function

ALT, AST < 4x IULN and serum total bilirubin  2.0 mg/dL

Cardiac function

Left ventricular ejection fraction  45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Wilmot Cancer Institute, University of Rochester · Rochester, New York

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