Platelets >= x ^/L within days of day of study
Effective March , , patients enrolled on AALL, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL or the HR B-ALL stratum of this study at the end of Induction: \r\n* Without favorable cytogenetics (no ETV-RUNX or double trisomies +), with day peripheral blood (PB) minimal residual disease (MRD) >= % and day BM MRD < .%\r\n* With favorable cytogenetics (ETV-RUNX or double trisomies +), with any day PB MRD and day bone marrow (BM) MRD >= .%\r\n* Both NCI standard risk (SR) and HR patients without Down syndrome and with testicular disease at diagnosis, who do not meet other VHR criteria
Thrombolytic use within days prior to first day of study therapy
Any prior intra-lesional MCC therapy within days from day of study treatment
Patients will be asked to refrain from having more than one alcoholic beverage per day
Ability to begin treatment in the extension (rollover) protocol within days following the last day of the study in the antecedent protocol
Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than months before Day or more than months prior to Day if platinum-based
Patient must be asymptomatic at time of getting SRS (day ) on trial; prednisone < mg/day for at least days prior to treatment is allowed
Subjects who consume more than alcoholic beverages per day
Treatment with systemic immune modulators weeks before enrollment (day )
Histological confirmation of follicular lymphoma grades I, II diagnosed within months ( days) prior to registration; NOTE: the day of biopsy should be used as day of diagnosis for this calculation
Patients should be asymptomatic for jaundice prior to Day .
History of any condition requiring anti-platelet therapy (aspirin > mg/day, clopidogrel > mg/day)
Chemotherapy within weeks of first dose of sEPHB-HSA (minimum of weeks for nitrosoureas and weeks for bone marrow transplantation) with the following exceptions:\r\n* Hydroxyurea allowed prior to, and up to day + of cycle of treatment (max mg/kg/day)\r\n* Corticosteroids allowed until day - (max dexamethasone mg/day)\r\n* Maintenance chemotherapy for ALL allowed one week prior to start of treatment (e.g., POMP)
Patients must have recovered from the effects of surgery per treating physicians judgment; there must be a minimum of days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of days must have elapsed prior to the day of protocol treatment
No platelet inhibitor drugs within days prior to infusion and during the immediate study Day follow-up period.
First detectable AdV DNA plasma viremia since the qualifying transplant occurred within days prior to Day .
Any CTCAE Grade or diarrhea (i.e., increase of ? stools per day over baseline), unless attributed to AdV, within days prior to Day
NIH Stage or higher acute GVHD of the gut (i.e., diarrhea > mL/m/day, or severe abdominal pain with or without ileus) within days prior to Day
Use of vasopressors within days prior to Day
Requirement for mechanical ventilation within days prior to Day , or sustained oxygen delivery for > hours within days prior to Day , or any oxygen requirement within hours prior to Day
Currently receiving or likely to require systemic immunosuppressive therapy from Day - to Day .
Off all but replacement dose of corticosteroids from Day - to Day (replacement dose is the patient's individualized dose defined for physiological replacement).
Off all but replacement dose of corticosteroids from Day - to Day (replacement dose is the patient's individualized dose defined for physiological replacement).
At time of day of protocol treatment, subjects with central nervous system metastases must have been treated and must be asymptomatic and meet the following:\r\n* No concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids\r\n* Neurologic stability (lack of signs and symptoms greater than baseline prior to x-ray therapy [XRT]) until the time of dosing\r\n* For radiation treatment, patients must not receive stereotactic radiosurgery or gamma knife treatment within days of day of protocol treatment; for whole brain radiotherapy (WBRT), there should be at least days between last day of WBRT and day of protocol treatment\r\n* Note: patients with leptomeningeal disease or cord compression are excluded from the study
Patients who have had an active infection requiring systemic therapy =< days prior to day - are not eligible UNLESS they are symptom-free and have a negative culture at the time of dosing on day -
Patient may have been pretreated with intermediate to high dose cytarabine (more than mg/m/d over d) if the day of the last infusion was at least days before inclusion in the study
Smoke at least cigarettes/day or carbon monoxide (CO) reading of at least ppm
Thrombolytic use (except to maintain i.v. catheters) or anticoagulant use within days prior to first day of study therapy
Patients must be beyond day and before day after transplant
Smoke an average of or more cigarettes or little cigars per day (CPD) prior to telephone screen
Patients must have recovered from the effects of surgery; there must be a minimum of days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of days must have elapsed prior to the day of protocol treatment
Febrile neutropenia or serious persistent infection within weeks prior to Day of treatment
Smoked at least cigarettes/day for at least year.
Patients with spinal cord compression or a history of leptomeningeal carcinomatosis. At the time of day of the study, patients with central nervous system metastases must have been treated and must be asymptomatic and meet the following criteria. . No concurrent treatment, inclusive of, but not limited to, surgery, radiation, and/or corticosteroids. (Note: patients are allowed on systemic steroids unless these are being administered to manage central nervous system metastases); . Neurologic stability (lack of signs or symptoms greater than baseline prior to radiotherapy) until the time of dosing of MEDI; . For radiation treatment, patients must be: at least days between last day of stereotactic radiosurgery or gamma-knife treatment and day of protocol treatment, at least days between last day of whole brain radiation therapy and day of protocol treatment, and/or at least days since last dose of corticosteroids and day of protocol treatment.
To be performed within days prior to day of protocol therapy: Normal eye examination
Hydroxyurea within hours prior to first day of study treatment.
Male patients unless they are using condoms as contraception starting on the day of transplantation up until one week after infusion
DOSE ESCALATION COHORT: Subjects with clinical condition where subjects may not tolerate immune mediated hepatotoxicity; this includes extensive liver metastasis, excessive intake of alcohol (male > drinks/day, female > drinks/day), and the use of acetaminophen > gms/day; per epacadostat investigators brochure
DOSE EXPANSION COHORT: Subjects with clinical condition where subjects may not tolerate immune mediated hepatotoxicity; this includes extensive liver metastasis, excessive intake of alcohol (male > drinks/day, female > drinks/day), and the use of acetaminophen > gms/day; per epacadostat investigators brochure
Peripheral edema requiring medical intervention within weeks prior to study day .
Patients unlikely to be available for evaluation at the transplant center on Day and of therapy.
Has had prior anti-myeloma therapy within weeks prior to study Day
Thrombolytic use (except to maintain i.v. catheters) within days prior to first day of study therapy
REGISTRATION # - PRIOR TO CONSOLIDATION CHEMOTHERAPY: Patients must have completed chemoradiotherapy per protocol and at least four weeks but no more than six weeks must have elapsed from the last day of induction therapy (the last day of radiation)
Up to months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day , with no radiographic evidence of disease progression or rising PSA levels prior to day ;
Up to months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day ;
Subject received treatment with -? reductase inhibitors (finasteride, dutasteride) within weeks prior to day .
Subject received treatment with estrogens, cyprotoerone acetate or androgens within weeks prior to day .
Has had prior anti-myeloma therapy within weeks prior to study Day
Treated with eculizumab for PNH for at least months prior to Day
Patients who have, within days prior to Day dosing:
Thrombolytic use (except to maintain i.v. catheters) within days prior to first day of study therapy
Patients who have received any investigational agent, chemotherapy, interferon-alpha, or -chlorodeoxyadenosine (-CdA, cladribine) within days prior to day ; or monoclonal antibody =< weeks prior to first administration of study treatment (patients with an AHNMD with progressive leukocytosis who require control of their counts are permitted to be given hydroxyurea); EXCEPTION: midostaurin can be used up to days before the start of the study drug (study day )
Hormone replacement therapies (estrogens, megestrol acetate) within days prior to day of protocol therapy
Current or recent (=< days prior to randomization) use of aspirin (> mg/day), or clopidogrel (> mg/day)
Use more than g/day of acetaminophen
Immunomodulatory therapy such as immunomodulatory drugs (Imids) or stem cell transplant within days prior to the first day of treatment
History of hormone replacement therapy (estrogens with or without progestin) or an aromatase inhibitor (anastrazole, letrozole, exemestane) within weeks prior to day
Current or recent (=< days prior to randomization) use of aspirin (> mg/day), clopidogrel (> mg/day), or prasugrel (> mg/day)
History of intracerebral abscess within months prior to Day
Platelet count > ^/L after months of at least g/day of hydroxyurea (. g/day in subjects with a body weight over kg) OR at the subject's maximally tolerated dose if that dose is < g/day.
In calculating days of tests and measurements, the day a test or measurement is done is considered day ; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day ; this allows for efficient patient scheduling without exceeding the guidelines; if day or falls on a weekend or holiday, the limit may be extended to the next working day
Prior treatment with dose dense regimens of temozolomide is not allowed (e.g, days on/ days off, day/ day and daily low dose continuous dosing). However, prior treatment with standard day - dosing in the adjuvant setting and low dose daily dosing as part of chemoradiation therapy are allowed
Washout periods for prior therapy are as follows\r\n* Bevacizumab last dose must be >= weeks prior to day of study treatment\r\n* Targeted therapy last dose must be >= half-lives prior to initiation of day of study treatment\r\n* Other chemotherapy, immunotherapy, or radiotherapy last dose must be =< weeks prior to day of study treatment
Palliative radiation therapy within weeks of Day , or within weeks of Day if a radionuclide was utilized.
At the time of day of the study, patients must be at least weeks since surgery.
Is, within weeks prior to Day , nursing.
Chemotherapy, radiotherapy, investigational anticancer therapy or major surgery within days of Day dosing with the following exceptions: a. Arm A: A minimum -day washout after discontinuation of ibrutinib therapy (or other BTK inhibitors) is required; only those subjects without rapid disease progression during the -day washout will be allowed to enroll into Arm A. i. Rapid disease progression is defined as follows:
For subjects with measurable nodal disease, the increase in the sum of diameters of the largest lymph nodes (up to nodes) exceeds cm per day OR the diameter of the largest lymph node exceeds cm during the day wash out. . For subjects with lymphocytosis, the increase in the ALC exceeds x/L per day OR the ALC exceeds , x/L during the -day wash out; b. Arm C: No minimum washout is required after discontinuation of ibrutinib (or other BTK inhibitors) c. Approved PI kinase inhibitors: Subjects may start study treatment within days of discontinuation of approved PI kinase inhibitors.
Patients that take acetaminophen (paracetamol) chronically, i.e. more than g/day for more than out of days, or more than g/day for more than day out of days
Local-regional therapy within weeks before Day
Have taken any of the following drugs within days prior to Study Day :
Interferon therapy < weeks prior to study day .
Peripheral edema ? grade within weeks prior to study day .
Stopped tobacco use for weeks prior to day and during the study
Negative serum or urine pregnancy test within days prior to and including the morning of day - (first potential day of research blood draw and tumor biopsy)
All pre-study labs required for determination of eligibility are to be completed within days prior to day - (or the next business day if falls on a weekend or holiday)
X-rays and/or scans to assess all disease sites are to be completed within days prior to day - (or the next business day if falls on a weekend or holiday)
Previous anti-cancer chemotherapy, immunotherapy or investigational agents < weeks, or palliative radiation < weeks prior to the first day of study treatment, or who have not recovered to grade or better from related side effects of such therapy (except alopecia); patients who receive gamma knife radiosurgery for brain metastases are eligible if procedure was performed > weeks before treatment is started, is clinically stable and has been on stable low dose corticosteroid treatment (e.g., dexamethasone mg/day, prednisolone mg/day for at least days before start of study treatment are eligible); ongoing hormonal therapies (luteinizing hormone-releasing hormone [LHRH] antagonists, megestrol) are allowed
Patients who consume more than alcoholic beverages per day
Have practiced yoga >= day a week within the months prior to enrolling in the study
Patient participants must also be a current smoker, defined as anyone who responds every day or some days to the question: Do you smoke cigarettes every day, some days, or not at all? (Behavioral Risk Factor Surveillance System [BRFSS])
Receiving chemotherapy (CTX) for breast, colon, rectal, small intestine, or ovarian cancer on a , , or day schedule with the chemotherapy dose given on day
For aim : Receiving CTX for a cancer diagnosis on a , , or day schedule with the CTX dose given on day
Planned administration of an investigational study drug or agent that either can interact with pamidronate or have an independent effect on bone mineral density within the weeks prior to randomization (day ) or planned use during study participation (day through day )
Impending invasive dental procedure that would be expected to occur during study participation (through day )
Prior to Administration of Ibrutinib (Day to Day post HCT)
PRIOR TO ADMINISTRATION OF IBRUTINIB (DAY -DAY POST SCT)
(Physician participation) seeing the patient in consultation on the day of the study
Individuals who are already meeting four or more of the six target dietary behaviors: >= servings/day of vegetables, >= servings/day of whole grains, >= servings/week of dark meat fish, no processed meat, no sweetened beverages, and =< alcoholic drink/day (d) for women and =< alcoholic drinks/d for men
Smoke >= cigarettes (cig)/day during the last week
No morphological evidence of disease (defined as marrow myeloblast percentage of < % and/or documentation from hematopathologist indicating no morphological evidence of leukemia) on day bone marrow examination (range, day -; day refers to the first day of IC) following remission IC
Between day + and day + status post myeloablative or nonmyeloablative UCBT (single or double cord blood transplant)
Dietary eligibility requirements from a -day food record fruit and vegetable (FV) intake less than < . servings/day, not including potatoes and iceberg lettuce
Patient who eats yogurt equal or more than once a day in the last days
Report sitting for >= accumulated waking hours on a typical day
Receiving anastrozole ( mg) or letrozole (. mg) orally once a day, for >= days prior to registration and plan to continue throughout the duration of study
Use of long acting opioids pre-operatively days prior to day of surgery
Describe fatigue as being present every day for most of day for a minimum of weeks
Describe fatigue as being present every day for most of the day for a minimum of weeks
Underactive (defined as physically active for less than minutes per day fewer than days per week)
Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day +/- days through day +/- days)
Watch less than hours of television per day
Smoke >= cigarettes per day
Smoke >= cigarettes per day for the last months
Smokes >= cigarettes per day (cpd)
Participants with a calcium intake >= mg/day measuring with hour dietary recalls
Participants with a calcium intake < mg/day measuring with hour dietary recalls
Current moderate-to-heavy smoker as determined by:\r\n* Has smoked greater than or equal to cigarettes per day regularly for the past year (by history) (greater than or equal to cigarettes per day for study ) and,\r\n* Has an expired carbon monoxide (CO) at screening visit of ppm or more ( ppm or more for study )
Has a condition or psychological difficulties that affects day-to-day activities
Women who are premenopausal, are on a stable contraceptive regimen, and are planning to continue the same regimen through surgery are eligible to participate; for women who are on hormonal contraception regimens that have a placebo phase, the following should be recorded regarding the day of baseline core biopsy and the day of surgery: the agent, whether they are in active or placebo phase, the day of the phase (e.g. day of -day active phase or day of -day placebo phase); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
Women who are using postmenopausal hormones, and are planning to continue the same regimen through surgery are eligible to participate; if the hormone therapy regimen is cyclical, the following should be recorded regarding the day of baseline core biopsy and day of surgery: the agent, the day of the phase (e.g. day of -day estrogen phase etc); this information will have to be back-calculated for the day of core biopsy, but best attempt should be made
Smoke or more cigarettes/day
Consumption of fewer than servings of fruits and vegetables per day
Have smoked cigarettes in their lifetime and currently smoke five or more cigarettes a day on average
Currently smoke at least cigarettes per day
Last anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) < weeks prior to study day or treatment with a therapeutic antibody less than weeks prior to study day as well as systemic radiation therapy within days prior to study day or focal radiotherapy within days prior to study day .
Smoke - cigarettes per day (cpd)
Able to recollect dietary intake for the prior hours in order to complete a one-day food record with assistance from a dietician at each study visit
Use of topical or systemic agents/treatments for OM within weeks of treatment day .
hospitalized for consolidation chemotherapy within day (+/- days)
Thrombolytic use (except to maintain i.v. catheters) within days prior to first day of study therapy