Acute Myeloid LeukemiaEarly Phase 1NCT03964506
Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
A Early Phase 1 study testing Hyperbaric oxygen in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Omar Aljitawi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Mar 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wilmot Cancer Institute, University of Rochester
Rochester, New York, 14642
Omar Aljitawi
Lisa Metzger
About this study
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
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.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Chronic Monocytic Leukemia, Myelofibrosis
- Being tested
- Hyperbaric oxygen
- Keywords
- Allogeneic transplant, Hyperbaric Oxygen
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Leukemia, Myeloid, Primary Myelofibrosis, Myelodysplastic-Myeloproliferative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenDrug
Also called HBO
Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hyperbaric oxygen |
| 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. Receives: Drug: Hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 100 days
Secondary outcomes (10)
Time to neutrophil recovery in Cohort 1
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Measured: 100 days
Time to neutrophil recovery in Cohort 2
based on the patient having achieved three consecutive days of Absolute Neutrophile Count (ANC) ≥ 500/microliter
Measured: 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
Measured: 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
Measured: 100 days
Incidence of mucositis in Cohort 1
Measured: 100 days
Incidence of graft versus host disease in Cohort 1
Measured: 100 days
Incidence of infection in Cohort 1
Measured: 100 days
Incidence of mucositis in Cohort 2
Measured: 100 days
Incidence of infection in Cohort 2
Measured: 100 days
Incidence of graft versus host disease in Cohort 2
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jul 2020
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Aljitawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Aljitawi, University of Rochester
- Investigators
- Omar S Aljitawi, MBBS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964506
- Sponsor's protocol ID
- UBMT-19163
- Status last verified
- Jun 2026
- First submitted
- 23 May 2019
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial will be shared after deidentification, including dictionaries.