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
Description:
Subjects with Acute Myeloblastic Leukemia (AML) and myelodysplastic syndrome (MDS), who are
considered eligible for allogeneic stem cell transplant by the transplant team at WCI(Wilmot
Cancer Institute) will be enrolled in the study. Melphalan 140mg/M2 will be given IV over
4-hours once on day -2 of the preparative regimen. Patients will receive HBO therapy 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.
Patients will be seen daily until neutrophil count engraftment is documented. After
neutrophil recovery is documented, the patients will be seen in clinic at least weekly
through day +100. A final visit will be scheduled day +100. As part of routine care, subjects
will be followed daily or as directed by the treating physician until neutrophil recovery,
defined as three consecutive days of achieving a neutrophil count of >500/mm3. Laboratory
testing will occur per institutional guidelines. Follow-up will continue until Day +100.
Donor chimerism and disease status will be determined by bone marrow biopsy on Day +30 and
day +100 post-transplant.
Condition:
Acute Myeloid Leukemia
Treatment:
Hyperbaric oxygen
Start Date:
March 2020
Sponsor:
Omar Aljitawi
For More Information:
https://clinicaltrials.gov/show/NCT03964506