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

Part of paid clinical trials in Rochester, New York.

Sponsor
Omar Aljitawi
Study ID
NCT03964506
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hyperbaric oxygen — DRUG
    Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant

Study Details

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.

Key Dates

Start date
Jul 1, 2020
Status verified
Jun 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1- AML or MDS
    Patients 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.
  • Experimental: Cohort 2- CMML, aCML, CML, CNL, MDS/MPN
    Patients 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.

Primary Outcome Measure

Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1 [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmot Cancer Institute, University of RochesterRochesterNew York14642
Omar Aljitawi
Lisa Metzger

Find similar trials in Rochester, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Wilmot Cancer Institute, University of Rochester· Rochester, NY

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