[c09aa8]: / clusters / clusters9k / clust_58.txt

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WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy for the entire study periodXx_NEWLINE_xXSubject is unable or unwilling to participate a study related procedureXx_NEWLINE_xXUnable or unwilling to discontinue use of any drug known to be a strong or moderate inhibitor or inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to first dose of study drug); unable or unwilling to discontinue use of any proton pump inhibitorXx_NEWLINE_xXIn the opinion of the Investigator patient is unable or unwilling to comply with the protocol.Xx_NEWLINE_xXPatients unable to comply with instructions for DIBHXx_NEWLINE_xXPatients must not be pregnant or breast feeding, or unable or unwilling to use proper contraception during the study and up to 3 months following study completion (for treatment phase)Xx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatient unable or unwilling to comply with the protocol requirementsXx_NEWLINE_xXPatients who are unwilling to comply with protocolXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnable/unwilling to undergo bone marrow samplingXx_NEWLINE_xXUnwilling or unable to comply with the requirements of the study protocolXx_NEWLINE_xXPatients unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXUnwilling or unable to provide written informed consent, comply with study requirements, or be available for follow-up assessmentsXx_NEWLINE_xXUnwilling to employ adequate contraceptionXx_NEWLINE_xXPatients unable to comply with the protocolXx_NEWLINE_xXAssessed by the investigator to be unable or unwilling to comply with the requirements of the protocolXx_NEWLINE_xXSubjects must be unwilling or unable to tolerate other non-study systemic chemotherapy.Xx_NEWLINE_xXDONOR: Donors who are unwilling or unable to sign informed consent (assent when appropriate)Xx_NEWLINE_xXPatient is unwilling or unable to comply with study procedures, or is planning to take vacation for 7 or more consecutive days during the treatment phase of the study without prior consent from the medical monitorXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXFor female patients of childbearing potential (defined as having had a menstrual period within the past 12 months): a positive serum pregnancy test (?-human chorionic gonadotropin [? HCG]) within 7 days prior to enrollment; or unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment; or if breastfeeding, unwilling or unable to stop breastfeeding while on study treatment.Xx_NEWLINE_xXPatients unable or unwilling to adhere to the study assessment schedule.Xx_NEWLINE_xXPatients unwilling or unable to comply with the study protocol.Xx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXThe subject or guardian is unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests.Xx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirements.Xx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests.Xx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXSubject is unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee.Xx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.Xx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients who are unwilling or unable to comply with all study requirementsXx_NEWLINE_xXPatients unwilling or unable to comply with the protocol.Xx_NEWLINE_xXPatients who are unwilling or unable to undergo an apheresis for production of their vaccineXx_NEWLINE_xXPatients unable or unwilling to provide informed consent.Xx_NEWLINE_xXPatients unable or unwilling to return to the transplant center for their assigned treatments.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staffXx_NEWLINE_xXPatients unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unable or unwilling to undergo a biopsy for research during the screening period, 2-3 weeks into the course of therapy and at the time of progressionXx_NEWLINE_xXUnable or unwilling to discontinue concomitant use of drugs that are known to prolong the QT interval.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to treatment.Xx_NEWLINE_xXSubjects must not be pregnant or unwilling to undergo pregnancy screeningXx_NEWLINE_xXPatients unable or unwilling to give written, informed consent.Xx_NEWLINE_xXPatients unwilling to comply with study protocolXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXPatient is unwilling or unable to comply with study proceduresXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnable or unwilling to follow post-therapy radiation protection proceduresXx_NEWLINE_xXPatients are not eligible if they are unwilling or unable to comply with the protocolXx_NEWLINE_xXUnable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigatorXx_NEWLINE_xXIs unwilling or unable to comply with study requirementsXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to minimize the risk of pregnancy for the entire study period and for at least 23 weeks after the last dose of investigational productXx_NEWLINE_xXPatient is unwilling or unable to follow the study schedule for any reasonXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reasonXx_NEWLINE_xXPatients who, in the investigator's judgment, are unwilling or unable to consent to and return for recommended post-treatment scans as outlined in this studyXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXDONOR: Unwilling or unable to provide informed consentXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXSubjects who are unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee are excludedXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatient is unable or unwilling to sign consentXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reasonXx_NEWLINE_xXUnable or unwilling to swallow the complete daily dose of ARQ 751Xx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXUnable or unwilling to tolerate an intracranial MRIXx_NEWLINE_xXSubject is unable or unwilling to discontinue use of prohibited medicationsXx_NEWLINE_xXSubject is unable or unwilling to participate in a study related procedureXx_NEWLINE_xXPatient is unwilling or unable to follow the study schedule for any reasonXx_NEWLINE_xXUnwilling or unable to stop oral supplemental vitamin DXx_NEWLINE_xXUnable to comply with protocolXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnwilling or unable to provide informed consentXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXAny significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to swallow ARQ 092 or anastrozole or comply with chemotherapy regimenXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to comply with the safety monitoring requirements of this protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients who are unwilling or unable to comply with study and/or follow-up proceduresXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnable to render informed consent and to follow protocol requirementsXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatients is unwilling or unable to comply with study proceduresXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatient is unable or unwilling to provide written informed consent or comply with follow-up scheduleXx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to, comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to sign informed consent documentXx_NEWLINE_xXPatients unwilling or unable to sign informed consent documentXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research testsXx_NEWLINE_xXPatients unwilling or unable to comply with the outlined protocolXx_NEWLINE_xXPatient unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnable or unwilling to give voluntary informed consent/assentXx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research testsXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXAssessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to complete study diaryXx_NEWLINE_xXAre unable or unwilling to follow protocol instructions and requirementsXx_NEWLINE_xXIs, in the judgment of the investigator, unable or unwilling to comply with the requirements of the study.Xx_NEWLINE_xXUnable or unwilling to undergo a 7 day washout period if currently being treated with deferiprone or deferoxamine or deferasirox;Xx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocol, or provide informed consent.Xx_NEWLINE_xXUnable or unwilling to adhere to the study-specified procedures and restrictionsXx_NEWLINE_xXPatients who are unable to provide informed consent, are incarcerated, or are unable to follow protocol requirements.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocol, or provide informed consentXx_NEWLINE_xXPatients unwilling or unable to comply with the protocol, or provide informed consentXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients with untreated AML who are either unwilling or unable to undergo high-dose induction/consolidation intensive chemotherapyXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXPatients who are unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designeeXx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational productXx_NEWLINE_xXPatients unwilling or unable to comply with the study protocolXx_NEWLINE_xXUnable and unwilling to provide informed consentXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXUnable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigatorXx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnable or unwilling to undergo protocol required thromboembolism prophylaxis(for Cohort C, this will be only for the subjects who have a history of VTE)Xx_NEWLINE_xXIs unable or unwilling to take folic acid or vitamin B12 supplementation.Xx_NEWLINE_xXSubjects unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatients who are unable to swallow oral medication or are unwilling to comply with the administration requirements are not eligibleXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXSubject is unwilling or unable to comply with study proceduresXx_NEWLINE_xXPatients unwilling or unable to comply with this study protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirements or to give informed consentXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnelXx_NEWLINE_xXSubject is unwilling or unable to comply with study proceduresXx_NEWLINE_xXPatients unable to comply with the protocol as judged by the investigator.Xx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to minimize the risk of pregnancy for the entire study period and for at least 12 weeks after the last dose of investigational productXx_NEWLINE_xXPatient unable to consent or comply with study guidelinesXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatients unwilling or unable to sign informed consent document.Xx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXIs unable or unwilling to participate in a study related procedureXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocol.Xx_NEWLINE_xXUnable or unwilling to sign the informed consent documentXx_NEWLINE_xXUnwilling to or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to comply with the protocolXx_NEWLINE_xXSubject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unable or unwilling to give written, informed consentXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXParticipants with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXPatient is unwilling or unable to follow the study schedule for any reasonXx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXMale subjects unable or unwilling to use adequate contraception methods from study start to 30 days after the last dose of protocol therapyXx_NEWLINE_xXUnable or unwilling to undergo antithrombotic prophylaxisXx_NEWLINE_xXUnwilling or unable to undergo a MRI or CT Scan per study protocol requirementsXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staffXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable to consent for studyXx_NEWLINE_xXUnwilling to use contraceptives while on study if relevant to patientXx_NEWLINE_xXAssessed by the investigator to be unable or unwilling to comply with the requirements of the protocolXx_NEWLINE_xXParticipants with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXPatients unwilling or unable to provide informed consent for the studyXx_NEWLINE_xXIs unable to follow study proceduresXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXParticipants unwilling or unable to comply with the protocolXx_NEWLINE_xXUnable or unwilling to swallow the complete daily dose of ARQ 087Xx_NEWLINE_xXPatients unwilling or unable to sign informed consent documentXx_NEWLINE_xXMale subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapyXx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research testsXx_NEWLINE_xXMale subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapyXx_NEWLINE_xXThe participant is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXMale subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapyXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the last dose of investigational productXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnable or unwilling to sign the consent formXx_NEWLINE_xXUnable or unwilling to discontinue use of prohibited medications for at least 7 days prior to the first dose of study drug and for the duration of the studyXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.Xx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to sign informed consent documentXx_NEWLINE_xXPatient is unable or unwilling to discontinue predefined prohibited medications listed in the protocol for 4 weeks of a drug (whichever is longer) prior to Visit 1 and for the duration of the studyXx_NEWLINE_xXPatients unwilling or unable to comply with protocol therapy, tests, and visits, or with a history of noncompliance with medical regimensXx_NEWLINE_xXEXPANSION COHORT ONLY: Patient is unable or unwilling to discontinue predefined prohibited medications listed in the protocol for 4 weeks of a drug (whichever is longer) prior to visit 1 and for the duration of the studyXx_NEWLINE_xXEXPANSION COHORT ONLY: Patients unwilling or unable to comply with protocol therapy, tests, and visits, or with a history of noncompliance with medical regimensXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXPatients unwilling to comply with the protocolXx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drugXx_NEWLINE_xXUnable or unwilling to provide informed consent.Xx_NEWLINE_xXUnable or unwilling to adhere to the study-specified procedures and restrictionsXx_NEWLINE_xXSubjects unwilling to or unable to comply with the protocol procedures as assessed by the InvestigatorXx_NEWLINE_xXSubject unwilling or unable to comply with study requirementsXx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research testsXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXIs unwilling or unable to abide by the requirements of the study.Xx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and procedures.Xx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unable to comply with the protocolXx_NEWLINE_xXSubject is unwilling or unable to comply with study procedures.Xx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of chemotherapyXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to take folic acid or vitamin B12Xx_NEWLINE_xXUnable or unwilling to complete the follow-up evaluations required for the studyXx_NEWLINE_xXUnwilling or unable to follow protocol requirements and the light exposure precautionsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatient is unwilling or unable to comply with study proceduresXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatient is unwilling or unable to comply with study proceduresXx_NEWLINE_xXPatient unable or unwilling to comply with the protocol requirementsXx_NEWLINE_xXMale subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapyXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXPatients unwilling or unable for any reason (personal, medical, or psychiatric) to comply with the protocolXx_NEWLINE_xXPatients unwilling or unable to comply with the study protocolXx_NEWLINE_xXUnwilling or unable to undergo a MRI per requirements in the study protocolXx_NEWLINE_xXUnwilling to consent to genomics samplingXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatient unable or unwilling to comply with the protocol.Xx_NEWLINE_xXSubjects unable or unwilling to comply with the study visit schedule and requirements of the studyXx_NEWLINE_xXSubjects who are unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures.Xx_NEWLINE_xXWoman of childbearing potential unwilling or unable to use adequate contraceptionXx_NEWLINE_xXUnwilling or unable to take oral medicationXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXMen unable or unwilling to employ 2 forms of highly effective contraception throughout the study and for 8 weeks after the end of study treatmentXx_NEWLINE_xXPatient is unwilling or unable to comply with the follow-up scheduleXx_NEWLINE_xXPatients unwilling or unable to comply with the research protocolXx_NEWLINE_xXIn Part 2, unable or unwilling to consent to provision of tumor tissue for GR assayXx_NEWLINE_xXIs unwilling or unable to comply with study procedures, or is planning to take a vacation for 7 or more consecutive days during the treatment phase of the studyXx_NEWLINE_xXUnable or unwilling to comply with all protocol requirements.Xx_NEWLINE_xXUnwilling to, or unable to, comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients with a history of alcohol abuse, or patients unwilling or unable to remain completely abstinent of alcohol during the study periodXx_NEWLINE_xXAssessed by the investigator to be unable or unwilling to comply with the requirements of the protocolXx_NEWLINE_xXPatients unwilling to use contraceptives while on studyXx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatients who are unable to take oral drugsXx_NEWLINE_xXWOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational productXx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staffXx_NEWLINE_xXUnwilling or unable to have a central venous catheterXx_NEWLINE_xXSubjects unable or unwilling to undergo antithrombotic prophylactic treatmentXx_NEWLINE_xXPatient is unable or unwilling to abide by the study protocol or cooperate fully with the investigatorXx_NEWLINE_xXPatients unable to comply with the protocolXx_NEWLINE_xXPatients unwilling to have a central catheterXx_NEWLINE_xXPatients who are unwilling or unable to comply with the protocol are not eligibleXx_NEWLINE_xXThe subject is unable or unwilling to stop taking vitamins, herbal remedy, or nonprescription medicationsXx_NEWLINE_xXThe subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designeeXx_NEWLINE_xXPatients unwilling to or unable to comply with the protocolXx_NEWLINE_xXPatients who are unable or unwilling to undergo antithrombotic therapy.Xx_NEWLINE_xXPatients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.Xx_NEWLINE_xXSubject is unwilling or unable to follow the procedures outlined in the protocol.Xx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXPatients who are unwilling or unable to comply with the protocolXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to comply with the protocolXx_NEWLINE_xXKEY INFORMANT: Unwilling to participateXx_NEWLINE_xXUnwilling or unable to participate in the studyXx_NEWLINE_xXUnwilling or unable to participate in group 3RP sessions delivered via the Partners Telehealth videoconferencing softwareXx_NEWLINE_xXUnable to comply with the protocol for any reasonXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to participate in the studyXx_NEWLINE_xXUnwilling or unable to participate in the studyXx_NEWLINE_xXUnwilling or unable to participate in the studyXx_NEWLINE_xXUnwilling to give consentXx_NEWLINE_xXUnable or unwilling to discontinue consuming soy-based food or supplements while participating in this studyXx_NEWLINE_xXAnyone who, in the investigator’s discretion, would be unwilling or unable to comply with study proceduresXx_NEWLINE_xXUnable and unwilling to provide informed consentXx_NEWLINE_xXUnwilling to give consentXx_NEWLINE_xXUnwilling to undergo routine follow-upXx_NEWLINE_xXAre unable or unwilling to discontinue anxiolytics within 4 hours of education sessionsXx_NEWLINE_xXSubjects who are unable or unwilling to discontinue use of prohibited medicationsXx_NEWLINE_xXUnable to cooperate with research proceduresXx_NEWLINE_xXUnable to provide medical historyXx_NEWLINE_xXUnwilling to receive acupuncture or unable to travel for treatmentsXx_NEWLINE_xXUnable or unwilling to sign consentXx_NEWLINE_xXPatients who are unable to follow instructions due to their medical conditionXx_NEWLINE_xXUnwilling or unable to participate in the studyXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to give written informed consentXx_NEWLINE_xXPatients unable to apply EstringXx_NEWLINE_xXUnable/unwilling to sign consentXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to provide informed consent or comply with the requirements of this protocol, including the presence of any condition (physical, mental or social) that is likely to affect the subject's return for scheduled visits and follow-up.Xx_NEWLINE_xXUnwilling or unable to comply with the protocolXx_NEWLINE_xXUnable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee.Xx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXThe patient is unwell or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to provide informed consentXx_NEWLINE_xXPatients unwilling to use contraceptionXx_NEWLINE_xXPatients who, in the judgment of the investigator, may be unable to participate in the required study proceduresXx_NEWLINE_xXUnable to comply with protocol and/or not available for follow-up assessmentsXx_NEWLINE_xXThose unwilling to participate in the follow-up call 3 months post-surgeryXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXBe unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessionsXx_NEWLINE_xXIs unwilling or unable to agree to swish and spit the study oral rinse three times per day during the study periodXx_NEWLINE_xXUnwilling or unable to sign and date the informed consentXx_NEWLINE_xXUnwilling or unable to comply with the follow-up scheduleXx_NEWLINE_xXPatients unwilling or unable to comply with the protocolXx_NEWLINE_xXUnable to comply with the protocol for any reasonXx_NEWLINE_xXUnable or unwilling to comply with study proceduresXx_NEWLINE_xXPatients unable to consent for the procedureXx_NEWLINE_xXUnwilling to complete baseline and follow-up questionnairesXx_NEWLINE_xXPatients unwilling or unable to provide consentXx_NEWLINE_xXUnwilling or unable to provide consentXx_NEWLINE_xXPatient unable to comply with the treatment protocol including appropriate supportive care, follow-up and research testsXx_NEWLINE_xXEXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Unwilling or unable to participate in all required study evaluations and proceduresXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXPatient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research testsXx_NEWLINE_xXPatients unwilling to comply with study requirementsXx_NEWLINE_xXUnable to understand instruction and to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to provide informed consentXx_NEWLINE_xXUnable or unwilling to adhere to study-specified proceduresXx_NEWLINE_xXSubjects unable or unwilling to comply with the study visit schedule and requirements of the studyXx_NEWLINE_xXPatients unwilling or unable to comply with the study protocolXx_NEWLINE_xXUnable or unwilling to adhere to a carbohydrate-restricted dietary interventionXx_NEWLINE_xXIf, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the StudyXx_NEWLINE_xXPatient unwilling or unable to provide informed consent.Xx_NEWLINE_xXUnwilling or unable to follow the protocol requirements.Xx_NEWLINE_xXSubjects unwilling or unable to given written informed consentXx_NEWLINE_xXSubject is unwilling to comply with the requirements of the protocolXx_NEWLINE_xXUnable to provide historyXx_NEWLINE_xXPatients unwilling or unable to sign informed consentXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXSubject is unable or unwilling to follow study requirements, including signed consent or assentXx_NEWLINE_xXParticipants unable or unwilling to give written, informed consent or to undergo MRI imagingXx_NEWLINE_xXUnable or unwilling to give informed consentXx_NEWLINE_xXPatients unable or unwilling to provide informed consentXx_NEWLINE_xXSubjects that are unable or unwilling to give informed consentXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnable or unwilling to give informed consentXx_NEWLINE_xXPatients who are unable to give consentXx_NEWLINE_xXPatients unwilling or unable to undergo the ecoil placement or multiparametric MRI examXx_NEWLINE_xXUnable or unwilling to discontinue concomitant drugs that are known to prolong the QT intervalXx_NEWLINE_xXUnable to understand, or unwilling to complete the informed consent processXx_NEWLINE_xXUnable or unwilling to follow protocol requirementsXx_NEWLINE_xXPatient under guardianship and/or unable or unwilling to cooperate with the requirements of this trialXx_NEWLINE_xXPatient is unable (or unwilling) to provide informed or surrogate (as appropriate) consentXx_NEWLINE_xXSubjects who are unable or unwilling to give informed consentXx_NEWLINE_xXPatients unwilling to undergo craniotomyXx_NEWLINE_xXUnable/unwilling to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXUnwilling or unable to follow protocol requirementsXx_NEWLINE_xXAre unwilling or unable to participate in, or do not have tissue adequate for participation in the biomarker analyses in the study.Xx_NEWLINE_xXUnwilling or unable to participate in the studyXx_NEWLINE_xXUnwilling or unable to receive home health careXx_NEWLINE_xXAre unable to consentXx_NEWLINE_xXPatients who are unable or unwilling to give informed consentXx_NEWLINE_xXMen whose partner is unwilling or unable to avoid pregnancyXx_NEWLINE_xXLactose-intolerance or are unwilling/unable to consume the protocol-specified standardized high-fat, high-calorie breakfast.Xx_NEWLINE_xX