Phase
Condition
Acute Myeloid Leukemia
Red Blood Cell Disorders
Leukemia
Treatment
Hyperbaric oxygen
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Wilmot Cancer Institute, University of Rochester
Rochester, New York 14642
United StatesActive - Recruiting
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