NCT03739502
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
Active, Not Recruiting
PHASE2Ages 18–70InterventionalTreatmentUniversity of RochesterInvestigator-initiated
~64 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Hyperbaric oxygen
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to neutrophil recovery
Measured over 100 days
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Omar Aljitawi · PRINCIPAL_INVESTIGATOR · University of Rochester
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Voluntary written informed consent
Patients who are considered for allogeneic transplantation based on their disease risk (see below) but lack matched sibling or unrelated donors or who are unable to proceed to allogeneic transplant within 8 weeks, will be considered for UCB transplantation on this study. Only patients for whom RIC will be considered are eligible. RIC is considered in those older than 45 or younger than 45 with Hematopoietic Cell Transplant (HCT) Comorbidity Index of 3 or higher (HCT) Comorbidity Index can be calculated using the following link: http://www.hctci.org/Home/Calculator
Patients with acute myeloid leukemia (AML) in CR1 that is not considered favorable-risk (favorable risk is defined as patients with t(15;17)(q22;q21), t(8;21)(q22;q22), inv(16)(p13q22)/t(16;16)(p13;q22), NPM1 mutation without FLT3-ITD, and double-mutated CEBPA58,59), AML in CR2 or subsequent CR, high-risk acute lymphoblastic leukemia (ALL) in CR1, or ALL in CR2 or higher, biphenotypic leukemia defined as coexpression of B-lymphoid and myeloid markers or T-lymphoid and myeloid markers in the blast population60or undifferentiated leukemia in ≥CR1. Myelodysplatic syndrome (MDS)/myeloproliferative neoplasm (MPN) patients with less than 10% bone marrow blasts and no peripheral blood blasts on pre-transplant bone marrow aspirate/biopsy are considered for FluCyTTBI regimen. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification61) Hodgkin's disease (HD) that relapsed following high-dose therapy. Chemotherapy sensitive (achievement of at least a partial response according to Lugano classification) non-Hodgkin's lymphoma (NHL) patients who relapsed post-high-dose therapy and autologous transplantation. Subjects should be enrolled within 30 days of transplant.
For ALL, high-risk features are defined using modified Hoelzer risk criteria62, these criteria are:
Subjects must be ≥ 18 years old and ≤ 70 years old
Karnofsky performance status (KPS) of ≥ 70% (Appendix A).
Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include:
ALT, AST: \< 4x IULN
Total bilirubin: ≤ 2.0 mg/dL
Creatinine: ≤ 1.5 x ULN
EF measured by 2D-ECHO or MUGA scan of ≥ 45%
FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin).
EKG with no clinically significant arrhythmia.
Patients should have New York Heart Association (NYHA) Functional Classification, class -1 (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina pain) or class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or angina pain).
Patients should be evaluated for fitness for HBO by a hyperbaric oxygen trained medical professional who is not part of the study team prior to starting preparative regimen.
Women of child-bearing potential should have a negative urine pregnancy test within 4 weeks of starting preparative regimen.
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:
Exclusion
Pregnant or breastfeeding
Severe chronic obstructive pulmonary disease requiring oxygen supplementation
History of spontaneous pneumothorax
Active ear/sinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, throat provider.
Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.
Prior chest surgery requiring thoracotomy or direct chest irradiation.
Recent of sinus or ear surgery, excluding myringotomy or ear tubes (within the last 5 years).
Claustrophobia
Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen.
History of seizures
No active tobacco use 72 hours prior to transplant until complete transplant recovery.
What this trial measures
- Time to neutrophil recovery100 days