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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 : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Omar Aljitawi, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Atypical Chronic Myeloid Leukemia Chronic Monocytic Leukemia Myelofibrosis Myelodysplastic/Myeloproliferative Neoplasm Drug: Hyperbaric oxygen Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Parallel 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 2023
Estimated Study Completion Date : March 2024


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

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.
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 transplantation in Cohort 1 [ Time Frame: 24 hours ]
    Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.

  2. Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2 [ Time Frame: 24 hours ]
    Treatment-limiting toxicities will be assessed 24-hours post-hyperbaric oxygen therapy.

  3. Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1 [ 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

  4. Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2 [ 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 in Cohort 1 [ Time Frame: 100 days ]
    based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter

  2. Time to neutrophil recovery in Cohort 2 [ Time Frame: 100 days ]
    based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter

  3. Time to complete donor chimerism in Cohort 1 [ 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

  4. Time to complete donor chimerism in Cohort 2 [ 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

  5. Incidence of mucositis in Cohort 1 [ Time Frame: 100 days ]
  6. Incidence of graft versus host disease in Cohort 1 [ Time Frame: 100 days ]
  7. Incidence of infection in Cohort 1 [ Time Frame: 100 days ]
  8. Incidence of mucositis in Cohort 2 [ Time Frame: 100 days ]
  9. Incidence of infection in Cohort 2 [ Time Frame: 100 days ]
  10. Incidence of graft versus host disease in Cohort 2 [ Time Frame: 100 days ]


Information from the National Library of Medicine

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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:

  • Voluntary written informed consent
  • Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
  • Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.
  • Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome for cohort 2.
  • Karnofsky performance status (KPS) of ≥ 70%
  • Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain).
  • Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST < 4x IULN and serum total bilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin)
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.
  • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
  • Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen

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 AML, MDS, CMML, aCML CML, CNL, MF and MDS/MPN overlap syndrome.
  • Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist.
  • Recent sinus surgery (within the last 5 years).
  • Ear surgery excluding myringotomy or ear tubes
  • Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed.
  • Claustrophobia
  • History of recurrent seizures within 5 years of study enrollment.
  • Uncontrolled 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
  • Patients who had intrathecal chemotherapy within 2 weeks of starting preparative 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: May 17, 2022
Last Verified: May 2022
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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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases