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New treatment option for Acute Myeloid Leukemia
Official title Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
ClinicalTrials.gov ID: NCT03964506
What this study is testing
What is Hyperbaric oxygen?
Hyperbaric oxygen is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as HBO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary written informed consent
- Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
- people with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.
- people with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL)...
- Karnofsky performance status (KPS) of ≥ 70%
You likely can't join if
- 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.
See the full eligibility criteria
- Voluntary written informed consent
- Men or women, age ≥ 18 years of age, with upper limit of 75 years old.
- people with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.
- people with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic/myeloproliferative (MDS/MPN) overlap syndrome...
- 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...
- 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...
- 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...
- 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...
- Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen
- 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.