Posted by on Jun 29, 2019 in Leukemia | 0 comments

In a nutshell

This study will investigate the effects of high-pressure oxygen on the transplant of umbilical cord blood stem cells in patients with blood cancers. The main outcome that will be measured is the time it takes for white blood cells to recover after treatment. This trial is recruiting in New York, US.

The details

Stem cell transplant (SCT) is commonly used as a treatment for many types of blood cancers. This involves the transfer of cells to the patient. Umbilical cord SCT involves the transfer of umbilical cord cells. Hyperbaric oxygen therapy is therapy with high-pressure oxygen. This is thought to improve the ability of stem cells to travel to the area within the body that they are required. 

This study will measure the effects of hyperbaric oxygen on umbilical cord blood (UCB) SCT. The main measurement will be the time it takes for the recovery of neutrophil (white blood cell) in the 100 days after treatment.

Who are they looking for?

This study will enroll 64 patients without a sibling or a matched unrelated donor. Only participants who are eligible to receive the pre-transplant, conditioning medication will be included. Patients must have adequate bone marrow, kidney, liver, lung, and heart function. Patients and their partners must agree to use effective birth control, before the study, during and 30 days after the study. For those with non-favorable acute myeloid leukemia, participants must have less than 10% immature white blood cells (blasts) in the bone marrow and blood. All participants must be enrolled in the study within 30 days of the SCT.

Those that are pregnant or breastfeeding will not be included. Those with lung diseases that require oxygen treatment, those with chest surgery or radiation cannot participate. Individuals with claustrophobia, a history of seizures and with ear or sinus problems will not be included.

How will it work

There will be two groups. Participants in group 1 will receive hyperbaric oxygen therapy. Participants in group 2 will not receive hyperbaric oxygen therapy. 

The main measurement will be the time it takes for the recovery of neutrophil (white blood cell) in the 100 days after treatment.

Clinical trial locations

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Type:Interventional
Participants:64
Study ID:NCT03739502
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