This trial will enroll patients 50 years and older with acute lymphoblastic leukemia (ALL). Patients above age 50 years are not eligible for intensive chemotherapy regimens and have been shown to have worse outcomes than adolescents and young adults treated with the same chemotherapy. For instance, the 5-year survival for patients aged 55-65 years treated on an international ALL trial was 21% compared to 38% for younger patients. Similarly, the 5-year survival for patients treated at MD Anderson Cancer Center with the hyper-CVAD regimen was 30% for patients aged 40-59 years compared to 51% for those less then age 40 years.
This research study is a prospective registry trial designed to evaluate the efficacy and safety of a novel decellularized human femoral artery allograft (Nexeon AVX) in the creation of vascular access for hemodialysis in patients with end stage renal disease (ESRD). Data from clinic visits will be collected for up to 2 years after treatment begins.
The InnAVasc Arteriovenous Graft is made from the same materials as standard care grafts, but with added medically safe materials that may make the graft easier to identify, safer to stick for dialysis, more durable, and less likely to bleed after your dialysis session when compared to standard care grafts. The InnAVasc Arteriovenous Graft is an investigational product, which means that this is not yet approved by government agencies like the U.S. Food and Drug Administration (FDA), but preliminary tests in the laboratory and in animals have proven safe enough to be allowed to be used in human clinical studies such as this.
At least 60 subjects will take part in this research at approximately 7 different medical facilities/hospitals in the United States. This will be the third time (3rd study) the InnAVasc Arteriovenous Graft will be used in human subjects.
This study is designed to learn more about how swallowing function works after completing reduced dose radiation after surgery. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and the initiation of radiotherapy within 28 days of signing the consent form. During treatment period some participants will receive reduced-dose radiotherapy and others will receive standard of care radiotherapy. In the follow up period participants will have visits every 3-6 months. Participation in this study may last up to two years. The swallowing function will be quantified using the MD Anderson Dysphagia index composite score 1 year after surgery. Some serious risk related to this study is that the reduced amount of radiation may not be as effective at curing this cancer compared to the standard dose. The most common risks and discomforts expected in this study are pain and swelling at the site of blood draw that may last several days. The main risk of this study is the increased risk of relapse. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this reduced dose works at curing this type of cancer. The study results may be used to help others in the future.