RecruitingEarly Phase 1NCT03964506

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

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


Sponsor

Omar Aljitawi

Enrollment

24 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) before and after a stem cell transplant improves outcomes for people with blood cancers like leukemia and myelodysplastic syndrome (MDS). Hyperbaric oxygen may help stem cells engraft and reduce transplant-related complications. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or certain other blood cancers (CMML, atypical CML, MDS/MPN) - You are scheduled to receive a stem cell transplant from a donor (allogeneic transplant) - You are in adequate health to undergo transplant **You may NOT be eligible if...** - You have a condition that makes hyperbaric oxygen therapy unsafe (e.g., untreated pneumothorax, severe lung disease, active ear infection) - Your cancer has not responded enough to prior treatment to qualify for transplant - You have severe organ dysfunction - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHyperbaric oxygen

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


Locations(1)

Wilmot Cancer Institute, University of Rochester

Rochester, New York, United States

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NCT03964506


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