Laboratory values adequate for patient to undergo surgery, including:
Screening laboratory values must meet the following criteria and should be obtained within 30 days (or 45 days if a biopsy is repeated) prior to study treatment:
Adequate organ function as indicated by laboratory values
Any of the following clinical laboratory values at the time of enrollment: (1) Absolute neutrophil count (ANC) <800/µL or (2) Platelets < 50,000/µL
Patient must have adequate organ function as indicated by the following laboratory values independent of transfusion within 2 weeks:
Laboratory values at the Screening Visit:
Must have the following laboratory values, obtained less than or equal to 7 days prior to registration:
Patients must have normal laboratory values as defined below:
Screening laboratory values must meet the following criteria:
Adequate organ function as defined by the following laboratory values at screening:
Impaired baseline organ function as evaluated by out-of-range laboratory values
Screening clinical laboratory values as specified below:
Adequate safety laboratory values:
Adequate organ function as determined by the following laboratory values:
Inadequate end organ function as defined by specified laboratory values
The following required Initial Laboratory Values should be obtained within 4 weeks of the start of treatment:
Subject has the following laboratory values at Screening:
Most recent laboratory values within 2 weeks prior to Week 1 Day 1 (W1D1) meet the following standards:
Inadequate organ and marrow function as demonstrated by any of the following laboratory values. Transfusions intended to elevate any parameters below solely for the intent of meeting study eligibility are not permitted.
Subject has adequate organ function as determined by the following laboratory values:
Adequate hematologic and organ function as confirmed by laboratory values
Adequate hematologic and organ function as confirmed by laboratory values
Laboratory values must be no older than seven (7) days prior to the start of therapy; if a test that is repeated after registration and prior to therapy is outside the limits for eligibility, it must be rechecked within 48 hours prior to the start of therapy; if laboratory values still fail to meet eligibility criteria, the patient may not receive protocol therapy
Abnormal clinical laboratory values within 14 days prior to initiation of dosing, as indicated by:
Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:
Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
Screening chemistry values of the following:
Adequate clinical laboratory values defined as:
Adequate baseline laboratory values collected within 7 days of starting the study treatment
Patients with abnormal laboratory values, defined as any of the following:
Patient has adequate organ function, as indicated by the following laboratory values
Have laboratory values (obtained ? 28 days prior to first infusion day) in accordance with the study protocol
Adequate organ function as determined by the following laboratory values:
Adequate organ function as indicated by the following laboratory values. All laboratory tests must be obtained within 7 days prior to the first dose of study treatment:
Serum biochemical values with the following limits unless considered due to leukemia:
Adequate baseline laboratory values collected no more than 7 days before starting study treatment
Clinical laboratory values as specified in the following:
Serum biochemical values with the following limits unless considered due to leukemia:
Adequate clinical laboratory values defined as:
The following laboratory values must be documented within 3 days prior to the first dose of study drug:
Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma)
Screening chemistry values of the following:
Patient must meet required laboratory values at the screening
Patient's clinical laboratory values meet any of the following criteria within the 7 days prior to Study Day 1:
-  Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.
Screening laboratory values:
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: platelets ? 100,000/mm^3
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: hemoglobin ? 9 g/dL
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: serum albumin ? 2.8 g/dl
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: calcium ? LLN
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: potassium ? LLN
BLADDER: Clinical laboratory values at screening: platelets ? 100,000/mm^3
BLADDER: Clinical laboratory values at screening: hemoglobin ? 9 g/dL
BLADDER: Clinical laboratory values at screening: serum albumin ? 2.8g/dl
Adequate laboratory values;
Adequate hematologic and organ function as confirmed by laboratory values
Clinical laboratory values within acceptable ranges within 72 hours prior to study day
Subject has the following laboratory values at screening:
Clinical laboratory values:
Adequate hematologic and organ function as confirmed by laboratory values
Abnormal laboratory values (unless due to underlying lymphoma)
Subject must have adequate organ function as indicated by the following laboratory values in the table below:
Screening clinical laboratory values:
Clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug):
Baseline laboratory values as follows:
Any abnormal laboratory values as specified in protocol
Patients with the following laboratory values during screening and on Day 1 predose:
Subjects must have adequate organ function as indicated by the following laboratory values.
Subject has adequate organ function as determined by the following laboratory values:
Screening laboratory values must meet the following criteria and should be obtained within 30 days (45 if biopsy is repeated) prior to study treatment:
Clinical laboratory values:
Laboratory values as follows at screening and within 7 days of planned first dose of therapy:
Adequate organ function defined as follows: System and Laboratory Values: Hematologic
Any of the following clinical laboratory values at the time of enrollment:
The following laboratory values:
Patients with abnormal laboratory values during screening and on day 1 of pre-dose
Screening laboratory values should be used to confirm subject eligibility. Laboratory results may be retested if necessary to confirm eligibility.
The patient has adequate serum chemistry levels, evidenced by the following laboratory values
Clinical laboratory values as specified in the protocol
Laboratory values fulfilling the following:
Have adequate organ function as defined by specified laboratory values
Clinical laboratory values as specified in protocol
Patients with abnormal laboratory values as defined by the protocol
Laboratory values as specified in study protocol
Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).
Laboratory values obtained ? 14 days prior to randomization:
Patients must have adequate organ function as indicated by the following laboratory values:
Clinical laboratory values as specified in the protocol Additionally, to be eligible for the Dose Expansion portion of the study:
Meeting the following laboratory values:
Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the Principal Investigator (PI) or study oncologist
Adequate organ function, demonstrated by the following laboratory values:
Adequate organ function and baseline laboratory values
Systemic disease must be such that laboratory values are within 1.5 x normal
Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
Any of the following baseline laboratory values:
Patients must have the following baseline laboratory values:
Adequate hematologic and organ function as confirmed by laboratory values at Screening:
All baseline laboratory requirements will be assessed and should be obtained within 14 days of first dose of study drug. Screening laboratory values must meet the following criteria:
Laboratory values and anticoagulation management per consensus guidelines, including:
Required screening laboratory values as described in the protocol
Patients with any of the following laboratory values at Screening/baseline
Laboratory values fulfilling the following:
Clinical laboratory values as specified below:
Clinical laboratory values as specified below within 3 days before the first dose of study drug:
Appropriate clinical laboratory values within 72 hours prior to study day 1:
Have adequate organ function as defined by specified laboratory values
Adequate clinical laboratory values during the screening period as specified in the protocol
Adequate clinical laboratory values during the screening period as specified in the protocol
Clinical laboratory values as specified within 14 days of treatment:
Patients must have the following clinical laboratory values:
Have adequate organ function as defined by specified laboratory values
Screening laboratory values:
Laboratory values fulfilling the following:
Patients must have clinical laboratory values meeting the following criteria within 28 days prior to registration:
Subject must have adequate organ function as indicated by the laboratory values below:
Patients whose laboratory values do not meet protocol criteria
Adequate organ function, as defined by the following criteria (per central or local laboratory values):
Adequate organ function as determined by the following laboratory values:
sustained clinically-significant worsening (investigator's assessment) from baseline granulocyte, platelet, or hemoglobin values (? 2 values, separated by ? 2 weeks)
Subjects must have the following laboratory values:
Subjects must have the following laboratory values at screening within 2 weeks of the first dose of investigational agents:
Most recent laboratory values (within 2 weeks prior to Week 1 Day 1 (W1D1)) before study entry meet the following standards:
Subjects must have the following screening laboratory values:
Clinical laboratory values and other measures as specified below within 28 days before the first dose of study drug:
Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:
Adequate organ function as defined per protocol
Demonstrate adequate organ function as defined below:
Adequate organ function as defined below:
Adequate organ function per protocol-defined criteria.
Adequate organ function defined as follows:
Have adequate organ function, defined as:
Adequate organ function (defined by the following parameters):
Adequate organ function defined as follows:
Adequate organ function as defined by and obtained within 28 days of starting treatment:
Adequate organ function, defined as follows:
Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) as defined in section 4.5
Poor vital organ function defined as:
Adequate organ function defined as:
Adequate organ function as defined by the following criteria:
Must have adequate organ function defined as:
Adequate organ function per protocol-defined criteria.
Subject has adequate pulmonary function defined as:
Adequate organ function as defined by the following criteria:
Must have adequate organ function, as defined by the following:
Adequate organ function as defined by:
Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:
Adequate organ function as defined below:
Adequate organ function as defined below:
Adequate organ function as defined by all the following criteria:
Patients must have adequate organ function at baseline as defined below: • Adequate liver function (within 7 days of crenolanib commencement), as determined by:
Adequate organ function as defined by the following criteria:
All patients must have adequate organ function defined as:
Has adequate organ function as defined by:
Adequate organ function as defined in the protocol
Has adequate organ function as defined by the following criteria:
Adequate non-hematologic organ system function, defined by:
Have adequate organ function defined by the protocol.:
Patients must have organ function as defined below:
Adequate organ function as defined by study-specific laboratory tests
Adequate organ function, as defined by the following criteria:
Adequate organ function per protocol-defined criteria.
Adequate organ function defined as:
Adequate organ function defined as follows:
Has adequate organ function as defined by protocol defined labs.
Adequate organ function defined as:
Adequate organ function as defined in the protocol
Adequate organ function at baseline as defined below. All laboratory assessments should be performed within 10 days of treatment initiation.
Have adequate organ function, as defined by the study protocol.
Adequate organ function as defined by the following criteria:
Adequate organ function per protocol-defined criteria.
Adequate organ function per protocol-defined criteria.
Adequate organ function per protocol-defined criteria.
Adequate organ function defined as follows:
Adequate organ function as defined below:
Has adequate organ function as defined by protocol
Organ Function Requirements - Subjects must have adequate organ functions as defined below:
Adequate organ function defined as:
Adequate baseline organ function as defined below
Adequate organ function, defined as:
Adequate organ function according to protocol-defined criteria
Adequate end organ function as defined by:
Adequate organ function as defined by the following criteria:
Adequate organ function defined as follows:
Adequate organ function defined as follows:
Adequate organ function defined as follows:
Adequate organ function defined as:
Adequate organ function defined as follows:
Adequate organ function defined as follows:
Adequate organ function as defined below:
Adequate organ function defined as follows:
Adequate organ function defined as below:
Adequate baseline organ function as defined in the protocol.
Adequate organ function as defined below:
Must have adequate organ function as defined by the following screening values (Retesting of borderline screening organ function and treatment with blood transfusions, growth factors etc. will be allowed):
Patients must have adequate organ function, as defined by the following parameter
Adequate organ function as defined by:
Patients must have adequate organ function, as defined by the following parameters:
Patients must have adequate organ function within 14 days prior to registration, as defined below:
Have adequate heart function defined as:
Organ Function Requirements: Subjects must have adequate liver function as defined by:
Organ Function Requirements: Subjects must have adequate liver function as defined by:
Acceptable pre-study organ function during screening defined as:
Subject must have adequate organ function as defined in the protocol.
Adequate end organ function as defined by:
Adequate organ function within 7 days prior to enrollment, as defined by the following criteria:
Adequate organ system function, defined as follows:
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Adequate end-organ function
Adequate hematologic and end organ function based on laboratory results obtained within 14 days prior to initiation of study treatment;
Adequate hematologic and end-organ function, defined by laboratory test results, obtained within 14 days before initiation of study treatment
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function Cancer-Related Inclusion Criteria:
Adequate hematologic and end-organ function
Adequate hematologic and organ function
Adequate hematologic and end-organ function
Adequate hematologic and organ function within 28 days before the first study treatment
Adequate hematologic and end organ function
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
The participant has adequate hematologic, organ, and coagulation function ?2 weeks (14 days) prior to first dose of study drug:
Adequate haematologic and end-organ function
Adequate hematologic and end-organ function
Have adequate hematologic, organ and coagulation function within 2 weeks (14 days) prior to enrollment.
Adequate hematologic and organ function
Adequate hematologic and end organ function obtained within 2 weeks prior to first dose of study drug
Adequate End organ function
Adequate hematologic and end organ function
Adequate end-organ function
Adequate end-organ function, as determined by laboratory tests obtained within 28 days prior to the first dose of study drug
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function.
Adequate hematologic and end organ function
Adequate hematologic and organ function within 28 days prior to initiation of study treatment
Adequate hematologic and end-organ function test results
Adequate hematologic and end organ function
Adequate hematologic and end organ function, confirmed by laboratory results obtained within 28 days prior to initiation of study drug
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end organ function
Adequate hematologic and end organ function
Adequate hematologic and end-organ function within 28 days prior to treatment initiation
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end organ function
Adequate hematologic and organ function within 14 days before the first study treatment
Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):
Adequate hematologic and end organ function
Adequate hematologic and end organ function Cohort 2-Specific Inclusion Criteria
Have adequate organ and hematologic function, as determined by:
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Patients must have adequate hematologic and organ function.
Adequate hematologic and end organ function
Acceptable hematologic and organ function
Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and organ function within 14 days before the first study treatment
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Patients must have normal organ and hematologic function therapy
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and organ function within 14 days prior to treatment initiation
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end organ function
Adequate hematologic, cardiac, and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end-organ function
Adequate hematologic and end organ function
Adequate hematologic and end-organ function
Adequate organ function
Adequate organ function
Adequate major organ function
Have adequate organ function.
Adequate organ function
Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).
Has adequate organ function
Adequate organ function
Demonstrate adequate organ function as evidenced by laboratory testing
Has adequate organ function.
Adequate organ function at baseline .
Patient must meet the organ function and system function requirements as stated in the protocol
Adequate organ function as measured by various blood parameters
Have adequate organ function.
Demonstrates adequate organ function
Adequate organ function.
Adequate organ function
Adequate organ function
Have adequate organ function
Adequate organ function
Have adequate organ function, including:
Have adequate organ function.
Have adequate organ function.
Adequate organ function
Poor organ function.
Demonstrates adequate organ function.
Adequate organ function.
Good organ function:
Must have adequate organ function.
Demonstrates adequate organ function.
Adequate organ function
Adequate organ function
Has adequate organ function
Have adequate organ function.
Has adequate organ function.
The patient has adequate baseline organ function, as demonstrated by the following:
Organ Function Requirements:
Adequate organ function within 14 days of study registration including:\r\n* Platelets >= 100 x 10^9/L
Adequate organ function within 14 days of study registration including:\r\n* Hemoglobin >= 8 g/dL
Organ function:
Subjects with adequate organ function as measured by:
adequate organ function
Adequate organ system function.
Patients must have adequate major organ function and meet the following criteria:
Demonstrate adequate organ function
Adequate organ function
Adequate baseline organ function within 14 days prior to the first dose of enzalutamide and/or CORT125281
ORGAN FUNCTION AND PERFORMANCE STATUS CRITERIA:
Adequate organ function at screening
Has adequate organ function
Has adequate organ function within 7 days before enrollment
Adequate organ function
-  Has adequate organ function.
Demonstrate adequate organ function
Adequate organ system function.
Have adequate organ function.
Evidence of insufficient organ function as determined by the protocol.
Candidate for pembrolizumab (as determined by physician, and adequate organ function)
Adequate organ function.
HEALTHY SUBJECT: Have adequate organ function
Adequate organ function.
Adequate organ function confirmed at Screening and within 10 days of initiating treatment, as evidenced by:
Adequate organ function within 14 days of study registration
Adequate organ function.
Patient has adequate organ function at Baseline
Adequate organ and neurologic function
Has adequate organ function including:
Adequate organ function
Have adequate organ function.
Adequate organ function
Have adequate organ function.
Potentially eligible for reduced intensity conditioning based on known organ function (formal organ function testing may occur after consent)
Have adequate organ function.
Adequate organ function
Organ function:
Patients must have adequate organ function
Adequate organ function within 14 days of registration
Adequate organ function
Acceptable end-organ function, except for documented exclusions for organ function compromise due to ALL itself
Adequate organ function
Organ Function Requirements:
Adequate organ function as outlined below (unless due to leukemia)
Adequate organ function
Adequate organ function including:
Adequate organ function
All organ function testing should be done within 28 days of study registration
Have adequate organ function.
Adequate organ function.
Adequate organ function
Patient has adequate organ function
Patients must have adequate organ function
Adequate organ system function within 14 days of baseline:
Poor organ function.
Has adequate organ function
Adequate organ function
Adequate organ function
Organ function characterized by ? Grade 1
Have adequate organ function
Patients must have adequate organ and system function.
Organ function must be adequate as follows:
Has adequate organ function
Adequate organ function.
Adequate organ function
Patient must meet the organ function and system function requirements as stated in the protocol
Adequate organ function as evidenced by:
Adequate organ function
-  The participant has adequate organ function:
Demonstrates adequate organ function.
Adequate organ function.
Adequate organ function
Demonstrates adequate organ function.
adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function:
Adequate organ function prior to registration
Adequate organ function
Adequate organ function
Adequate organ function
Demonstrates adequate organ function
Demonstrates adequate organ function.
Adequate organ function
Has adequate organ function
Have adequate organ function.
Adequate organ function as shown by:
Hemodynamically stable and adequate organ function
Poor organ function.
Adequate organ function
Adequate organ function.
Demonstrates adequate organ function.
Adequate organ function
Adequate organ function
Adequate organ function
Chemistry panel obtained 30 days prior to registration on study, with adequate organ function
Have adequate organ function.
Adequate organ function
Adequate organ function
Has adequate organ function.
Patients must have adequate organ function:
Must have adequate organ function as demonstrated by the following:
Adequate Organ Function
have adequate organ function
Adequate organ function
Have adequate organ function.
Demonstrates adequate organ function
Has adequate organ function
Organ Function
Demonstrate adequate organ function as detailed above
Have adequate organ function.
Adequate organ function
Have adequate organ function
Adequate baseline organ function.
Adequate organ function
Adequate organ function
Have adequate organ function including:
Have adequate organ function
Adequate baseline organ function, as demonstrated by the following:
Adequate organ function
Demonstrated adequate organ function within 14 days of treatment initiation.
Have adequate organ function.
Has adequate organ function
Adequate organ function
Adequate organ function including:
Adequate organ function
Adequate organ function.
Adequate organ function
The participant has adequate organ function.
The participant has adequate organ function, including:
Subject has adequate organ function.
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function
Adequate organ function including:
Adequate organ function
Adequate organ function within 14 days of dosing
Adequate organ function
Has adequate organ function
Adequate major organ system function
Adequate organ function including:
Adequate organ function including:
Have adequate organ function;
Adequate organ function
Adequate baseline organ function
Have adequate organ system function
Patients with adequate organ function as measured by:
Adequate organ function
Has adequate organ function
The participant has adequate organ function.
Adequate organ function as evidenced by the following laboratory findings:
Adequate organ function within 10 days of Day 1
Has adequate organ function
Demonstrates adequate organ function.
Adequate baseline organ function.
Adequate organ function within 3 weeks prior to first study drug administration as evidenced by:
Adequate organ function per blood work
Adequate organ function
Adequate organ function as shown by:
Adequate baseline organ function
Have adequate organ function
Subject has adequate organ function.
Adequate organ function
Adequate organ function.
Adequate organ function including:
Has adequate organ function, before the first dose of study drug.
Adequate organ function.
Adequate organ function including the following:
Adequate organ system function.
Adequate organ function
Adequate organ function
Demonstrate adequate organ function.
Adequate organ function
Acceptable organ function as evidenced by the following:
Adequate organ function.
Have adequate organ function.
Have adequate organ function.
Have adequate organ function.
Adequate organ function as determined by the following laboratory results, within 28\n             days prior to randomization
Adequate organ function within 14 days of study entry
Adequate organ function
Adequate organ function at baseline:
Have adequate organ function.
Adequate organ function
Adequate organ function, including the following:
Adequate organ function:
Adequate organ function including:
Adequate baseline organ function.
Adequate organ function
Adequate organ function
Organ function </= grade 1.
Adequate organ function
Adequate organ function;
Adequate organ function
Adequate organ system function determined within 14 days prior to first dose of study treatment.
Adequate organ function.
At the time of the CMV specific T cell infusion, the recipient must have adequate organ function as indicated by < grade 3 across all organ systems except for hematologic toxicity
Have adequate organ function, including:
Adequate organ function.
Adequate organ system function.
Patients with adequate organ function as measured by:
Has adequate organ function as determined by laboratory tests
adequate organ function
Adequate organ function, including the following:
Adequate other organ function at screening and enrollment.
Adequate other organ function at screening and enrollment.
Participants must have adequate organ function, including the following:
Life expectancy of at least 12 weeks. - Adequate organ function
All organ function testing should be done within 28 days of study registration
Adequate organ function
Adequate organ function including:
Has adequate organ function.
Has adequate organ function
Adequate organ function including:
Adequate baseline organ function:
Have adequate organ function
Adequate organ function
Organ function requirements:
Adequate organ function determined within 14 days prior to enrollment
Adequate organ function.
Must have adequate organ function, including the following:
Adequate organ function as determined by the investigator
Demonstrates adequate organ function, within 10 days prior to the start of study drug.
Adequate organ function as per protocol.
Has adequate organ function
Adequate organ function
Evidence of adequate organ function by standard laboratory tests.
Female subject must either:
Female subject must either:
The subject is pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test; NOTE: female subjects of childbearing potential are required to have a negative qualitative serum pregnancy test at the time of enrollment and within twenty-four (24) hours prior to the first dose of the investigational product\r\n* Female subject of childbearing potential is defined as follows:\r\n** Subject with regular menses\r\n** Subject with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Subject with history of tubal ligation\r\n* Female subject not of childbearing potential is defined as follows:\r\n** Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n** Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old
Female subject not of childbearing potential is defined as follows:\r\n* Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n* Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old
Female subject must either:
Note: Female subjects of childbearing potential are required to have a negative qualitative serum pregnancy test at the time of enrollment and within twenty-four (24) hours prior to the first dose of the investigational product\r\n* Female subject of childbearing potential is defined as follows:\r\n** Subject with regular menses\r\n** Subject with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Subject with history of tubal ligation\r\n* Female subject not of childbearing potential is defined as follows:\r\n** Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n** Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old
Female subject must either:
Female subject must either:
Female subject must either:
Female subject is either:
One of the following is required: Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female subject or female partner of a male subject; Additional barrier method: contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female subject or female partner of a male subject. For male subject or male partner of female subject, vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy) performed at least 6 months before Screening. Tubal ligation in the female partner of a male subject performed at least 6 months before Screening. Established and ongoing use of oral, injected, or implanted hormonal contraceptive by female partner of a male subject.
If female, subject must be either:
Female subject must be either:
A female subject is eligible to enter the study if she is:
Female subject must either:
Female subject must either:
Female subject must either:
Female subject must either:
Female subject must be either:
A female subject is eligible to participate if she is of:
Female subject must either be:
Female subject must either:
Impaired cardiac function
Impaired cardiac function.
Impaired cardiac function
Impaired cardiac function or history of cardiac problems
Impaired cardiac function or history of cardiac problems
Impaired cardiac function
Impaired cardiac function (defined futher in the protocol)
Known impaired cardiac function including any one of the following:
Impaired cardiac function
Impaired cardiac function
Impaired cardiac function
impaired cardiac function
Impaired cardiac function including any of the following:
Impaired cardiac function
Impaired cardiac function including any one of the following:
Phase 2: Measurable disease meeting the following criteria:
Adequate hepatic function within 28 days prior to study registration defined as meeting all of the following criteria:
Adequate hematologic function within 28 days prior to study registration defined as meeting all of the following criteria:
Have adequate hematologic function within 15 days prior to study treatment, defined as meeting all of the following criteria:
Unilateral or bilateral disease meeting study criteria
Donor meeting 1 of the following criteria:
Any patient not meeting the eligibility criteria
The presence of measurable disease meeting the following criteria:
Meeting the protocol definition of TNmCRC assessed in the screening blood test.
Multiple myeloma meeting the following criteria:
Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment:
Disease-related: meeting one of the following diagnosis
Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
Active disease meeting ? 1 of the following IWCLL 2008 criteria for requiring treatment
Active disease meeting ? 1 of the following IWCLL 2008 criteria for requiring treatment.
Measurable disease based on investigator's assessments meeting the following criteria:
Must have documented progressive disease by meeting at least one of the Prostate Cancer Working Group 2 Criteria
Positive serology for HTLV 1 or 2. Furthermore and prior to lymphodepleting chemotherapy, a subject meeting the following criteria is not eligible for participation in the study:
Patients must have progressive mCRPC defined by meeting at least one of the following criteria:
Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:
Adequate hepatic function within 28 days prior to registration for protocol therapy defined as meeting all of the following criteria:
Adequate hematologic function within 28 days prior to registration for protocol therapy defined as meeting all of the following criteria:
Subjects have active disease meeting the IWCLL 2008 published criteria.
Presence of measurable disease meeting the following criteria:
Have adequate hematologic function, defined as meeting all of the following criteria:
Has, at screening, serologic laboratory tests meeting one or more of the following criteria:
Has, at screening, safety laboratory tests meeting one or more of the following criteria:
mTNBC (confirmed from most recent tissue sample) meeting the following criteria:
Presence of measurable disease meeting the following criteria:
Cardiac or peripheral vascular disease meeting any of the following criteria:
Patient must have an advanced stage malignancy defined as meeting at least one of the following criteria:
Measurable multiple myeloma disease, defined as meeting at least one of the following criteria within 14 days prior to first dose of study drug:
Laboratory values meeting the following criteria:
Presence of measurable disease meeting the following criteria:
Radiologically measurable disease meeting the following criteria:
Completed primary treatment (surgery, chemotherapy, and/or radiation) at minimum 6-8 weeks before the first group meeting, and maximum 24 months before the first group meeting, which approximates the ‘re-entry’ phase of cancer survivorship.
Multiple myeloma meeting the following criteria:
Participants who were eligible for the main trial with the exception of not meeting BMI criteria for obesity
Measurable disease meeting the following criteria and confirmed by central radiographic review:
Adequate renal function
Adequate renal function
Adequate renal function:
Acceptable liver and renal function
Adequate renal function
Adequate renal function
Adequate liver and renal function
Adequate Renal & Liver Function.
Adequate renal function within 28 days prior to study registration defined by either of the following criteria:
Adequate renal function.
Subjects must have adequate renal function
Adequate renal function, defined as:
Adequate renal function
Adequate renal function.
Adequate renal function
Adequate renal function:
Participants must have adequate renal function, defined as:
Adequate renal function
Renal Function as follows:
Adequate renal function defined as follows:
Adequate renal function:
Renal function:
Renal Function:
Have adequate renal function as defined by the following criterion:
Adequate renal function:
Adequate Renal Function:
Acceptable renal function
Renal Function: Adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.
Adequate renal function, defined as:
Acceptable renal function
Adequate liver and renal function
Adequate renal function
Have adequate renal function
Acceptable renal function
Adequate liver and renal function
Subject has adequate renal function, which is defined as:
Renal function defined as:
Acceptable liver and renal function:
Adequate liver and renal function
Adequate renal function
Acceptable renal function
Adequate renal function
Adequate renal function within 28 days prior to registration for protocol therapy defined by either of the following criteria:
Adequate renal function
Adequate renal function
Adequate cardiac and renal function
Adequate renal function.
Adequate renal and liver function
Must have adequate renal function
Adequate renal function
Acceptable renal function
Adequate renal function
Adequate haematological, liver and renal function
Adequate renal function
Adequate liver, renal and cardiac function
Adequate renal function
Adequate renal function
Acceptable renal function
Adequate renal function (as defined in the study protocol)
Renal function, as follows:
Renal function:
Adequate renal function:
Adequate Renal function
Adequate renal function.
Adequate renal function.
Renal: Adequate renal function
Adequate renal function
Compromised renal function
Adequate renal function within 28 days prior to C1D1
Adequate renal function defined as:
Subject has adequate organ and marrow function.
6. Adequate organ and marrow function;
Adequate organ and marrow function
Adequate organ and marrow function
Must have adequate organ and marrow function
Subjects with adequate organ and marrow function
Adequate organ and marrow function as defined below:
Have adequate normal organ and marrow function, including the following:
The patient has adequate organ and marrow function as follows:
Adequate organ and marrow function
Patients must have adequate organ and marrow function as determined by the treating oncologist
Subjects must have adequate organ and marrow at screening as defined below:
The patient has adequate organ and marrow function per protocol
Adequate organ and marrow function
Adequate normal organ and marrow function
Adequate organ and marrow function as determined by medical oncology evaluation
Adequate organ and marrow function
Adequate organ and marrow function
Adequate organ and marrow function, defined per protocol
Adequate organ and marrow function
Adequate organ and marrow function
Subjects must have adequate organ and marrow function as defined below:
Adequate organ and marrow function
Adequate organ and marrow function
Adequate organ and marrow function
Adequate organ and marrow function
Adequate organ and marrow function , as defined below:
Adequate organ and marrow function.
Adequate organ and marrow function.
Patients must have adequate organ and marrow function as defined below
Adequate organ and marrow function
Adequate organ and marrow function
Acceptable organ and marrow function ?21 days prior to registration:
Adequate organ and marrow function
Adequate organ and marrow function
Adequate organ and marrow function
Adequate organ and marrow function
For all tumor types, adequate organ and marrow function, as defined below:
Adequate organ and marrow function:
Adequate organ and marrow function
Adequate organ and marrow function
Patients are eligible regardless of organ/marrow function
Participants must have adequate organ and marrow function to proceed to transplant
Adequate organ and marrow function.
Participants must have organ and marrow function within the following parameters within 16 weeks before Segment B enrollment:
No organ and marrow function requirements
No restrictions will be made based on organ or marrow function
Requirements for organ and marrow function are not applicable to this study, but function will need to be sufficient to undergo planned therapy
No requirements for organ and marrow function
The patient has adequate organ and marrow function as follows:
Adequate organ and marrow function
Laboratory and medical history parameters not within protocol-defined range
Acceptable laboratory parameters and adequate organ reserve
Acceptable laboratory parameters
Laboratory parameters:
Adequate laboratory parameters
Laboratory and medical history parameters not within the Protocol-defined range.
Acceptable laboratory parameters
Laboratory parameters for vital functions should be in the normal range or not clinically significant.
Laboratory parameters: Hematology:
Has acceptable, applicable laboratory parameters.
Patients who have poor organ function as defined by laboratory parameters specified in the protocol.
Acceptable laboratory parameters
Acceptable laboratory parameters
Unable to meet radiation treatment plan parameters
Laboratory parameters outside the protocol-defined range.
Laboratory and medical history parameters outside Protocol-defined range.
Laboratory parameters not within the protocol-defined range.
Adequate laboratory parameters
Screening laboratory parameters:
Subjects must meet the following laboratory parameters:
Must meet the following laboratory parameters:
Adequate organ function as determined by following laboratory parameters:
Hematology laboratory parameters within the Protocol specified range
Chemistry laboratory parameters within the Protocol specified range
Laboratory parameters:
Laboratory and medical history parameters not within Protocol-defined range
Laboratory and medical history parameters within protocol-defined range.
Meet the following laboratory parameters:
Meet the following laboratory parameters:
Laboratory and medical history parameters not within the Protocol-defined range
Acceptable laboratory parameters and adequate organ reserve.
Laboratory parameters not within the protocol-defined range.
Laboratory values within protocol -defined parameters
Pretreatment clinical laboratory values must meet protocol-defined parameters during the screening phase
Adequate study baseline laboratory parameters
If not specified above as tumor specific parameter subjects must have the following laboratory and hematologic parameters as follows:
Pretreatment clinical laboratory values must meet protocol-defined parameters during the Screening phase
Laboratory and medical history parameters not within the Protocol-defined range.
Acceptable laboratory parameters and adequate organ reserve.
Patients must have baseline laboratory tests within the following parameters within 14 days prior to registration:
Laboratory parameters for vital functions should be in the normal range or not clinically significant.
Laboratory parameters for vital functions should be in the normal range. Laboratory abnormalities that are not clinically significant are generally permitted, except for the following laboratory parameters, which must be within the ranges specified, regardless of clinical significance:
Adequate laboratory parameters
Adequate laboratory parameters
Must meet the following laboratory parameters:
Laboratory values within protocol-defined parameters
Subjects must meet the following laboratory parameters:
Laboratory and medical history parameters not within protocol-defined range.
Adequate baseline laboratory parameters.
Laboratory parameters not within the protocol-defined range
Have the following laboratory parameters (may be assessed locally):
Laboratory parameters not within the protocol-defined range.
Haematological parameters:
Biochemical Parameters:
Adequate laboratory parameters [absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters] at screening
Acceptable laboratory parameters and organ reserve
Laboratory and medical history parameters not within the Protocol-defined range
Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study
Laboratory values obtained =< 365* days prior to registration:\r\n* Note: Without medical situations that should change these parameters since they were done
Adequate laboratory parameters [absolute neutrophil (ANC), platelets, asparate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters] at screening
Acceptable laboratory parameters and adequate organ reserve.
Acceptable laboratory parameters
Note: Exceptions to laboratory (lab) parameters may be allowed with approval of the Protocol Chair
Laboratory parameters outside the protocol-defined ranges.
Acceptable laboratory parameters and adequate organ reserve.
Laboratory and medical history parameters not within the protocol-defined range.
Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb, total bilirubin, ALT, AST and GFR)
Laboratory and medical history parameters not within the protocol-defined range
NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start
Hemoglobin >/= 9 g/dL Hepatic Function
Hepatic function as follows:
Adequate hepatic function as evidenced by:
The following criteria for evidence of adequate hepatic function performed within 2 weeks prior to study entry must be met:
Adequate hepatic function
Adequate hepatic function
Subjects with documented hepatic metastases involving >50% of the hepatic parenchyma.
Adequate hepatic function:
Patients must have adequate hepatic function as evidenced by:
The following criteria for evidence of adequate hepatic function performed within 28 days prior to randomization must be met:
Adequate hepatic function
Adequate hepatic function.
Adequate hepatic function, as follows:
Adequate hepatic function
Adequate hepatic profile.
Adequate hepatic profile:
Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
Adequate hepatic function
Hepatic function, as follows:
Adequate hepatic function as defined as follows:
Adequate hepatic function defined as:
The patient has adequate hepatic function per protocol
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests defined aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline (Alk) phosphatase (Phos), and or total bilirubin greater than 2.5 times the upper limit of normal; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
Hepatic function:
Hepatic Function:
Have adequate hepatic function as defined by the following criteria:
Hepatic
Adequate hepatic function:
Has adequate hepatic function, defined as:
The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met:
Patient must not have a diagnosis of hepatic encephalopathy
History of hepatic disease or significant hepatic dysfunction
Adequate hepatic function performed within 4 weeks prior to study entry must be met:
Hepatic metastases
Adequate hepatic function within 48 hours prior to induction chemotherapy
Adequate hepatic function
Have adequate hepatic function
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria; patients with active hemolysis should be excluded; no distinction should be made between liver dysfunction due to metastases and liver dysfunction due to other causes; this data will be captured in the case report form (CRF); registration laboratory investigations will be used to assign a patient to a hepatic function group; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients’ group assignment being altered if different to registration test results
Hepatic encephalopathy refractory to medical therapy
Hepatic Function:
Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
Have adequate hepatic function.
Adequate hepatic function
History of hepatic encephalopathy
Any history of hepatic encephalopathy
Ongoing or recent hepatic encephalopathy
Any history of hepatic encephalopathy
Hepatic function:
The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met:
Hepatic function:
Adequate hepatic function
Presence of hepatic encephalopathy within 4 weeks of 1st dose
Patient has adequate hepatic function defined as:
Patients must have adequate hepatic function, defined as
Hepatic
Hepatic encephalopathy
Subjects must have adequate hepatic function as evidenced by:
Adequate hepatic function is defined by the following:
History of hepatic encephalopathy
Hepatic encephalopathy
Subjects must have adequate hepatic function as evidenced by:
Adequate hepatic function as evidenced by serum bilirubin values < 2.0 mg/dL; ALT and/or AST < 3xULN.
Patients with more than 30% replacement of hepatic parenchyma by tumor or any history of drug related hepatic encephalopathy
Adequate hepatic function
Hepatic
Adequate hepatic function with bilirubin < 1.5 mg/dl
Adequate hepatic function.
Must have adequate hepatic function
Adequate hepatic function
Adequate hepatic function
Has adequate hepatic function as evidenced by:
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
Known active hepatic disease
Participants with abnormal hepatic function
Patients must have adequate hepatic function, defined as:
Hepatic:
Hepatic function, as follows:
Hepatic function, as follows:
Recipient must have adequate hepatic function as defined by a total bilirubin <3x upper limit of normal or absence of hepatic fibrosis/cirrhosis.
Adequate hepatic function:
Hepatic encephalopathy, per the investigator's evaluation.
Adequate hepatic function per institutional standards
Alcoholism or hepatic disease.
Adequate hepatic function.
Adequate hepatic function.
Basic metabolic and hepatic function panels
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests (previously documented alanine aminotransferase greater than 40 IU/dL and/or plasma aspartate aminotransferase greater than 45 IU/d); patients who have a history of hepatic dysfunction or hepatic disease but whose most recent liver function tests have been documented as normal will be eligible to participate
Chronic hepatic disease
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
Adequate hepatic function defined as:
No parenchymal hepatic metastases
Clinically detectable hepatic encephalopathy or hepatic encephalopathy requiring medication
Adequate hepatic function within 28 days prior to C1D1
Patients with history of hepatic dysfunction or hepatic disease
Episodes of hepatic encephalopathy within the last 4 weeks. Patients with prior episodes of hepatic encephalopathy who are clinically stable on lactulose, neomycin, and/or xifaxan therapy are allowed.