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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964506
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Omar Aljitawi, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Drug: Hyperbaric oxygen Early Phase 1

Detailed Description:
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. Fludarabine 30mg/M2 will be given IV over 30-60 minutes on days -6 to -2 and 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Hyperbaric Oxygen Therapy
Patients 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.
Drug: Hyperbaric oxygen
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
Other Name: HBO




Primary Outcome Measures :
  1. Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant [ Time Frame: 24 hours ]
    Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.

  2. Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant [ Time Frame: 100 days ]
    Possible long-term effects of hyperbaric oxygen therapy treatment prior to allogeneic peripheral blood stem cell transplant will be assessed at day +100 post-transplant


Secondary Outcome Measures :
  1. Time to neutrophil recovery [ Time Frame: 100 days ]
    based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter

  2. Time to complete donor chimerism [ Time Frame: 100 days ]
    Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964506


Contacts
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Contact: Regulatory Coordinator (585) 276-7078 Lisa_Metzger@URMC.Rochester.edu

Locations
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United States, New York
Wilmot Cancer Institute, University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Omar Aljitawi         
Contact: Lisa Metzger         
Sponsors and Collaborators
Omar Aljitawi
Investigators
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Principal Investigator: Omar S Aljitawi, MBBS University of Rochester
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Responsible Party: Omar Aljitawi, Associate Professor of Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT03964506    
Other Study ID Numbers: UBMT-19163
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data collected during the trial will be shared after deidentification, including dictionaries.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available immediately following publication. No end date.
Access Criteria: Anyone who wishes to access the data for any type of analyses.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omar Aljitawi, University of Rochester:
Allogeneic transplant
Hyperbaric Oxygen
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases