Early Phase 1 Leukaemia Trial, Recruiting NCT03964506 Sponsor: Omar Aljitawi Condition: Leukaemia
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Early Phase 1 Leukaemia Trial, Recruiting

NCT03964506
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to give written consent to take part voluntarily.
  • You are a man or woman between 18 and 75 years old.
  • You have been diagnosed with acute myeloid leukemia (AML) or a bone marrow condition called Myelodysplastic Syndrome (MDS) (this is for the first group in the trial).
  • You have been diagnosed with one of several other blood or bone marrow conditions, including CMML, aCML, CML, CNL, myelofibrosis, or MDS/MPN overlap syndrome (this is for the second group in the trial).
  • Your general health and ability to carry out daily activities meets a certain minimum level, as measured by a standard scoring tool (confirm with trial site).
  • Your heart is functioning well enough that everyday activities cause little or no symptoms such as tiredness, shortness of breath, or chest pain.
  • Your liver, kidneys, heart, and lungs are working well enough to be considered for a transplant, based on specific blood and scan results (confirm with trial site for exact values).
  • If you could become pregnant, or if your partner could become pregnant, you agree to use reliable contraception before, during, and for 30 days after the treatment — and to tell your doctor immediately if pregnancy occurs or is suspected.
  • If you are a woman who could become pregnant, you have a negative pregnancy test (urine or blood) within 4 weeks of starting the treatment.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You have severe lung disease (COPD) that requires you to use supplemental oxygen.
  • You have a history of a collapsed lung (spontaneous pneumothorax), prior chest surgery involving opening the chest, or radiation treatment directed at your lungs.
  • A recent chest scan (within the last 60 days) shows a collapsed lung or significant scarring of the lungs.
  • You currently have another active cancer, other than the blood or bone marrow conditions listed above.
  • You currently have an active ear or sinus infection, or you have chronic sinus problems unless an ear, nose, and throat specialist has confirmed it is safe for you to participate.
  • You have had sinus surgery within the last 5 years.
  • You have had ear surgery (other than a minor procedure such as ear tubes or a small eardrum incision).
  • You are not willing to stop smoking tobacco or using e-cigarettes starting 72 hours before the transplant and until you have fully recovered (nicotine replacement products such as patches or gum are allowed).
  • You experience claustrophobia (fear of enclosed spaces).
  • You have had repeated seizures at any point in the last 5 years.
  • You have asthma that is not well controlled.
  • You currently have a viral or bacterial infection that is not under control.
  • You have had a serious fungal infection in the past 6 months that has not been reviewed and approved by an infectious disease specialist (confirm with trial site).
  • You have received chemotherapy injected into the fluid around the spine within the last 2 weeks, or radiation to the head within the last 4 weeks, before starting the treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Omar S Aljitawi, MBBS, University of Rochester

Phone: (585) 276-7078

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Omar Aljitawi
Registry
ClinicalTrials.gov
Start date
1 July 2020
Est. completion
1 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in Cohort 1; Immediate safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplantation in cohort 2; Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 1; Long term safety of hyperbaric oxygen therapy prior to allogeneic stem cell transplant in Cohort 2

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov