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Pure oxygen using a hyperbaric chamber given before umbilical cord blood transplant to help engraftment and the immune system recover faster after transplant

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18 - 70

Phase 2

1 Location

NCT03739502

Clinical Trial Goal


To find out if giving pure oxygen before umbilical cord blood transplant is safe and helps your immune system recover faster after transplant

You may be able to join this trial if you:


  • Are 18 – 70 years old
  • Have one of the following diseases:
    • Acute myeloid leukemia (AML)
    • Acute lymphoblastic leukemia (ALL)
    • Biphenotypic leukemia
    • Chronic myelomonocytic leukemia (CMML)
    • Juvenile myelomonocytic leukemia (JMML)
    • Hodgkin lymphoma
    • Non-Hodgkin lymphoma (NHL), including:
      • Burkitt lymphoma
      • Diffuse large B-cell lymphoma (DLBCL)
      • Follicular lymphoma
      • Mantle cell lymphoma
      • Marginal zone B-cell lymphoma
      • Small lymphocytic lymphoma (SLL)
      • Other non-Hodgkin lymphoma
      • Waldenström's macroglobulinaemia
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Hyperbaric oxygen (HBO) therapy involves breathing pure oxygen in a special chamber. You’ll lay in a bed that’s enclosed and sealed. The pressure in the chamber is increased, and the air will be 100% oxygen. Doctors think this therapy may help the blood-forming cells from the umbilical cord blood get to your bone marrow more quickly after transplant.

In this trial, you will be randomized to 1 of 2 groups. Once you are randomized, you’ll be told which group you’re in:
  • Group 1 – HBO therapy plus umbilical cord blood transplant
  • Group 2 – Umbilical cord blood transplant

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.

Everyone will get standard chemo to prepare your body for transplant and treatment to prevent GVHD.

If you’re in Group 1, before transplant, you’ll get HBO therapy and breathe pure oxygen for a number of hours.

Then, on transplant day, the blood-forming cells from the umbilical cord blood are given to you through an intravenous (IV) infusion.

You'll have biopsies to see how well the treatment and transplant are working. The clinical trial doctors will check your health for about 3 months after your transplant.

The Food and Drug Administration (FDA) has approved HBO therapy to help your body heal from certain wounds. Using HBO therapy before umbilical cord blood transplant is new and unproven.

Contacts


Kaitlyn Burrows, (585) 275-5150, Kaitlyn_Burrows@URMC.Rochester.edu

Locations


University of RochesterRECRUITING

Rochester, New York

ClinicalTrials.gov record


NCT03739502. First posted on 11/13/18

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