Normal organ and marrow function:
Patient must meet the organ function and system function requirements as stated in the protocol
Patients must have normal or near normal organ function as defined by their treating institutions BMT program clinical practice guidelines.
Poor organ function.
Good organ function:
Poor vital organ function defined as:
Organ Function Requirements:
Organ function:
ORGAN FUNCTION AND PERFORMANCE STATUS CRITERIA:
Evidence of insufficient organ function as determined by the protocol.
PRE-SCREENING: Must have normal organ function with liver function tests (LFTs) < . x upper limit of normal (ULN)
Potentially eligible for reduced intensity conditioning based on known organ function (formal organ function testing may occur after consent)
Normal organ and bone marrow function defined as:
Organ function:
Acceptable end-organ function, except for documented exclusions for organ function compromise due to ALL itself
Normal bone marrow and organ function as defined below:
Organ Function Requirements:
All organ function testing should be done within days of study registration
Poor organ function.
Patients must have normal organ function as defined below:
Other serious co-morbid illness or compromised organ function
Organ function characterized by ? Grade
Patients must have normal organ function as defined below:
Normal organ and bone marrow function as defined by:
Patient must meet the organ function and system function requirements as stated in the protocol
Multi-organ failure
Patients must have organ function as defined below:
Acceptable organ and marrow function during the Screening Period as defined by the\n protocol.
Poor organ function.
Patients must have normal organ and bone marrow function measured within days of randomisation,
Have organ and marrow function at the screening and pre-dose visits as defined by:
Patients must have normal organ and marrow function as defined below:
Organ Function
Patients must have normal organ and marrow function documented within days of study enrollment as defined below:
Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy
Patients must have normal marrow function as defined below:
Patient must have normal bone marrow and organ function as defined below
Patients must have normal organ and marrow function as defined below:
ECOG performance status ? Patients must have normal organ and marrow function as defined below:
Subjects must have normal organ and bone marrow function measured within days prior to administration of study treatment;
Acceptable bone marrow and organ function at screening;
Other serious co-morbid illness or compromised organ function
Patient must meet the organ function requirements as stated in the protocol.
Patients must have normal organ and marrow function as defined below:
Acceptable organ and marrow function ? days prior to registration:
Acceptable organ function as evidenced by the following:
Patients must have normal organ and hematologic function therapy
Patients must have normal organ and marrow function as defined below:
Must have normal organ and marrow function reported within days prior to randomization
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):
The subject has poor organ and marrow function as defined in the protocol.
Subject must have normal organ and marrow function as defined below:
Patients must have normal organ and marrow function as defined below:
Patients must have normal organ and marrow function
Organ function </= grade .
At the time of the CMV specific T cell infusion, the recipient must have adequate organ function as indicated by < grade across all organ systems except for hematologic toxicity
Normal organ function tests including Creatinine
Normal organ function tests including Bilirubin
Normal organ and marrow function.
Other serious co-morbid illness or compromised organ function.
Patients are eligible regardless of organ/marrow function
All organ function testing should be done within days of study registration
Regarding non-hematologic organ function, no specific criteria for non-hematologic organ function are specified; however, if moderate-to-severe (major) organ function is present, such should be discussed with the PI, as various degrees of non-hematologic organ dysfunction may compromise either (or both) toxicity and response evaluations; also, if there is concern regarding potential reversibility of any specific organ dysfunction, this issue should also be addressed by consultation with an appropriate sub-specialist
Participants must have organ and marrow function within the following parameters within weeks before Segment B enrollment:
No organ and marrow function requirements
No restrictions will be made based on organ or marrow function
Normal organ and marrow function
Organ Function Requirements Patients without bone marrow metastases must have an ANC > /?l and platelet count >,/?l.
Acceptable pre-study organ function during screening defined as:
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
Normal organ and marrow function within limits as defined below:
Organ function requirements:
Patients must have normal marrow function as defined:
Subjects must have normal organ and marrow function as defined below:
Subjects must have normal organ and marrow function as defined below: