RecruitingPhase 2NCT03739502

A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant

A Randomized Phase II Study Evaluating the Efficacy of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplantation


Sponsor

University of Rochester

Enrollment

64 participants

Start Date

Feb 28, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether breathing oxygen under high pressure (hyperbaric oxygen therapy) before a stem cell transplant using umbilical cord blood can improve how well the transplant takes and grows in patients with blood cancers. **You may be eligible if...** - You have a blood cancer (such as leukemia or lymphoma) that requires a stem cell transplant - You do not have a fully matched sibling or unrelated donor, or you cannot get a matched transplant within 8 weeks - A reduced-intensity conditioning (gentler preparation) transplant is planned for you - You are willing to undergo hyperbaric oxygen treatment before transplant **You may NOT be eligible if...** - A fully matched donor is available and you can proceed quickly - You are not eligible for a reduced-intensity transplant regimen - You have conditions that prevent you from safely being in a hyperbaric chamber (e.g., severe lung disease, claustrophobia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHyperbaric oxygen

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs). However, UCB as a graft source for a bone marrow transplant has drawbacks related to the limited cell dose available for transplant and defects in homing. Homing is the process of UCB stem cell lodging in the bone marrow. If the homing is not efficient it could delay the re-population of the stem cells (or engraftment), possibly lead to engraftment failure, and delay the rebuilding of the immune system after transplant. This could, in turn, provide a higher risk to infection after the UCB transplant.


Locations(1)

University of Rochester

Rochester, New York, United States

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NCT03739502


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