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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1- AML or MDS | Experimental | 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. |
|
| Cohort 2- CMML, aCML, CML, CNL, MDS/MPN | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen | Drug | Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1 | Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy. | 24 hours |
| Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2 | Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy. | 24 hours |
| Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1 | 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 | 100 days |
| Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2 | 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 | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neutrophil recovery in Cohort 1 | based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter | 100 days |
| Time to neutrophil recovery in Cohort 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Coordinator | Contact | (585) 276-7078 | Lisa_Metzger@URMC.Rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Omar S Aljitawi, MBBS | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Institute, University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
All individual participant data collected during the trial will be shared after deidentification, including dictionaries.
Data will be available immediately following publication. No end date.
Anyone who wishes to access the data for any type of analyses.
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|
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
| 100 days |
| Time to complete donor chimerism in Cohort 1 | Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care | 100 days |
| Time to complete donor chimerism in Cohort 2 | Bone marrow chimerism will be checked on day +30 and day +100 Bone Marrow (BM) samples according to our standard of care | 100 days |
| Incidence of mucositis in Cohort 1 | 100 days |
| Incidence of graft versus host disease in Cohort 1 | 100 days |
| Incidence of infection in Cohort 1 | 100 days |
| Incidence of mucositis in Cohort 2 | 100 days |
| Incidence of infection in Cohort 2 | 100 days |
| Incidence of graft versus host disease in Cohort 2 | 100 days |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D007951 | Leukemia, Myeloid |
| D055728 | Primary Myelofibrosis |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009196 | Myeloproliferative Disorders |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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