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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects with Acute Myeloblastic Leukemia (AML) and myelodysplastic syndrome (MDS) who are considered eligible for reduced intensity conditioning allogeneic stem cell transplant by the transplant team at WCI (Wilmot Cancer Institute)will be enrolled in the study. Patients will receive Fludarabine starting day -6 and Melphalan on day -2 and HBO (Hyperbaric Oxygen) therapy on day 0 of the transplant. Subjects will be followed for any toxicity related to therapy. After neutrophil recovery is documented, the patients will be seen in clinic at least weekly through day +100.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Omar Aljitawi
• Treatments: Fludarabine; Melphalan

Criteria

Inclusion Criteria:

• subjects with acute Myeloid Leukemia (AML)

• subjects with Myelodysplastic Syndrome

• Karnofsky performance status (KPS) of greater than 70% Adequate Hepatic, renal, cardiac and pulmonary function Women of child-bearing potential and men with partners of child-bearing potential who agree to use adequate contraception

Exclusion Criteria:

• pregnant or breastfeeding

• severe chronic obstructive pulmonary disease requiring oxygen supplementation

• history of spontaneous pneumothorax

• prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs

• evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant

• active malignancy excluding Myeloid Leukemia (AML) or Myeldoysplastic Syndrome (MDS)

• active ear/sinus infection

• history of sinus or ear surgery, excluding myringotomy or ear tubes

• no active tobacco use 72 hours prior to transplant

• claustrophobia

• history of seizures

• asthma uncontrolled viral or bacterial infection at the time of study enrollment

• active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval.

• intrathecal chemotherapy within 2 weeks of starting peparative regimen or cranial irradiation within 4 weeks of starting preparative regimen