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

Last updated: April 1, 2025
Sponsor: Omar Aljitawi
Overall Status: Active - Recruiting

Phase

1

Condition

Acute Myeloid Leukemia

Red Blood Cell Disorders

Leukemia

Treatment

Hyperbaric oxygen

Clinical Study ID

NCT03964506
UBMT-19163
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) forcohort 1.

  • Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloidleukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, andmyelodysplastic/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 infatigue, palpitation, dyspnea, or anginal pain).

  • Adequate hepatic, renal, cardiac and pulmonary function to be eligible fortransplant. Minimum criteria include: Hepatic: ALT, AST < 4x IULN and serum totalbilirubin ≤ 2.0 mg/dL; Renal: serum creatinine: ≤ 2.0 mg/dL; Left ventricularejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinicallysignificant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected toserum hemoglobin)

  • Women of child-bearing potential and men with partners of child-bearing potentialmust agree to use adequate contraception (hormonal or barrier method of birthcontrol; abstinence) prior to study entry, for the duration of study participation,and for 30 days following completion of therapy. Should a woman or partner becomepregnant or suspect she is pregnant while participating in this study, she shouldinform 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 thefollowing criteria: Has not undergone a hysterectomy or bilateral oophorectomy; orHas not been naturally postmenopausal for at least 12 consecutive months (i.e., hashad menses at any time in the preceding 12 consecutive months)

  • Women of child-bearing potential should have a negative urine or serum pregnancytest within 4 weeks of starting preparative regimen

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Severe chronic obstructive pulmonary disease requiring oxygen supplementation

  • History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy ordirect 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 overlapsyndrome.

  • Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches areexcluded 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 priorto transplant until complete transplant recovery. Nicotine replacement therapy isallowed.

  • 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 withoutinterdisciplinary (ID) consult and approval

  • Patients who had intrathecal chemotherapy within 2 weeks of starting preparativeregimen or cranial irradiation within 4 weeks of starting preparative regimen

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Hyperbaric oxygen
Phase: 1
Study Start date:
July 01, 2020
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • Wilmot Cancer Institute, University of Rochester

    Rochester, New York 14642
    United States

    Active - Recruiting

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