Patients receiving chronic pharmacologic doses of corticosteroids are not eligible; for the purposes of eligibility, chronic exposure is defined as anticipated exposure of > weeks, including the sum of both pre-enrollment and anticipated post-enrollment dosing; patients on acute corticosteroid therapy (=< weeks of total planned exposure) must still meet the normal blood glucose requirement; patients receiving chronic inhaled corticosteroids or chronic physiologic replacement doses of corticosteroids are eligible
Chronic bronchitis or emphysema requiring oxygen therapy within the last months
Chronic gastrointestinal illness
Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
Chronic use of immune-suppressive drugs (ie, systemic corticosteroids used in the management of cancer or non-cancer related illnesses, eg, COPD).
Received systemic glucocorticoids within days prior to the first dose of enzalutamide and/or CORT, or requirement for chronic or frequently used systemic glucocorticoids for medical conditions (e.g., rheumatoid arthritis, immunosuppression after organ transplantation)
Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL\r\n* Included subtypes will be: acute, lymphomatous, and chronic unfavorable; chronic unfavorable is defined as the chronic variant with at least one of the following: lactate dehydrogenase (LDH) > upper limit of normal (ULN), blood urea nitrogen (BUN) > ULN, albumin < lower limit of normal (LLN)\r\n* Positive HTLV- antibody testing with confirmatory testing via western blot, enzyme-linked immunosorbent assay (ELISA), or molecular testing (polymerase chain reaction [PCR])
Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
FOR ALL PHASES (Ib AND II): Chronic oxygen therapy
Patients must not have a history of the following immunosuppressive conditions: bone marrow transplantation and/or organ transplants and/or chronic rheumatic conditions that require active immunosuppressive therapy; patients with a history of chronic lymphoid or leukemic malignancies which are not under active therapy (no active therapy within the last months) will be eligible; patients with chronic lymphoid or leukemic malignancies are eligible with or without active disease as long as they have not had treatment within the past three months
The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness
Has chronic, active colitis
PHASE I: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, irritable bowel disorder [IBD], muscular sclerosis [M.S.], uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., chronic obstructive pulmonary disease [COPD])\r\n* Known human immunodeficiency virus [HIV]-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
PHASE II: A history of autoimmune disorders\r\n* Patients with autoimmune disease other than vitiligo (e.g., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason are excluded from the study; any patient with an allo-transplant of any kind would be excluded as well, including xenograft heart valve; mild, intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded\r\n* Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, e.g., COPD)\r\n* Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due the possibility of affecting the response to tremelimumab, and the higher risk of active opportunistic infections
Chronic usage of aspirin greater than mg/day
Treatment with chronic immunosuppressants
Treatment with chronic immunosuppressants
Active autoimmune disease, chronic inflammatory condition, conditions requiring concurrent use of any systemic immunosuppressants or steroids; mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded
Ongoing treatment with chronic immunosuppressants.
Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
Chronic treatment with glucocorticoids within one year
Chronic use of steroid therapy.
Concomitant therapy with immune-suppressants or chronic use of systemic corticosteroids
Prior use of any chronic systemic glucocorticoids .
Chronic use of corticosteroids
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma, excluding inhalation steroids for maintenance.
Is receiving chronic corticosteroids administered at doses greater than those used for normal replacement therapy
Chronic ongoing oral steroid use at the time of registration for any condition (such as asthma, rheumatoid arthritis, etc)
Be self-reported to be immune-compromised (human immunodeficiency virus [HIV], chronic immunomodulators, chronic corticosteroids)
chronic insomnia
Prior history of chronic prostatitis
Have a chronic underlying infection
Subjects should be willing to abstain from use of hormonal therapies (e.g. hormone replacement therapy, oral contraceptive pills, hormone-containing IUDs, and E-string) and chronic NSAID's for the duration of the study (chronic use of NSAID's is defined as a frequency > times/week for more than two weeks per year and includes low dose aspirin).
People who are on long-term (> year) chronic treatment are eligible
Chronic glucocorticoid or acute glucocorticoid or other synthetic steroid intake within the last month
Chronic hepatic disease
Patients with chronic active arthritis
Chronic inflammatory conditions
Known chronic aspiration
Chronic gabapentin, or the similar drug pregabalin, use
Chronic steroid use
Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
History of chronic myopathy
History of chronic sinusitis or recent nasal polyps
History of chronic myopathy
Use of chronic laxatives (>= consecutive days)
History of chronic myopathy
Has an uncontrolled chronic diarrheal illness
History of chronic sinusitis or recent nasal polyps
No findings in the rectum of advanced adenoma, chronic inflammation, or cancer
Immunocompromised (due to conditions including HIV infection, hematopoietic-cell or solid organ transplantation, and chronic glucocorticoid use) men and women of any ethnic group aged ? years.
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin; short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted
history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
AND with one or more of the following highly prevalent ambulatory-sensitive chronic conditions (diabetes, hypertension, chronic lung disease, chronic kidney disease, depression, or heart disease).