[c09aa8]: / clusters / ordered9kclusters / clust_1878.txt

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Age >/=18 years at the time the ICF is signed
Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
Must be ? 18 years of age at the time of signing the ICF.
Subject is ? 18 years of age at the time of signing the informed consent form (ICF).
Men or women ? 18 years old at the time of signing the ICF
Participant is considered a legal adult by local regulation at the time of signing informed consent form (ICF).
Must be ? 18 years of age at the time of signing the ICF.
Subject is 1 to < 21 years of age at the time of signing the Informed Consent Form/Informed Assent Form (ICF/IAF).
Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)
Patients ?18 years of age at the time of signature of the ICF
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF)
Has read, understood, and signed the ICF
Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
Has read and understands the informed consent form (ICF) and has given written ICF prior to any study procedures
Male or female is 1 to ? 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
Subject is male or female, ? 18 years old at the time of signing the informed consent form (ICF).
Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
Age ? 65 years at the time of signing the informed consent form (ICF). 11. Central confirmation of diagnosis of one of the following untreated AML as per WHO classification (Appendix I):
Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement for ? 3 months prior to signing the ICF; or
Significant active cardiac disease within the previous 6 months prior to signing the ICF, including:
Patients must have the ability to understand, and have signed an approved ICF
Subjects must be ?18 years of age at the time of signing the Informed Consent Form (ICF);
Men and women ? 18 years of age, at the time of signing the informed consent form (ICF).
All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).
Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the ICF
Females or males, aged >=18 years at the time of signing the informed consent form (ICF).
Platelet >= 75,000 cells/mm^3, +/- 7 days from date of ICF signing
Hemoglobin > 9 g/dL, +/- 7 days from date of ICF signing
Adult male or female ? 18 years of age at the time of signing the informed consent form (ICF).
No prior anti-cancer therapy for the treatment of metastatic disease at the time of signing the ICF. Adjuvant treatment is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence.
Venous thromboembolism within 1 month prior to signing ICF.
Treatment with any investigational product within 28 days prior to signing the ICF.
Prior exposure to an investigational agent or device within 30 days of signing the ICF. Of note, the subject may participate in observational studies;
Signed ICF
Both men and women in the rituximab combination arm (Cohort B) must practice contraception as described above from the time of signing of the informed consent form (ICF) through 12 months after the last dose of study drug.
Males or females age ?18 years at the time of informed consent form (ICF)
Has the ability to read and understand subject Informed Consent Form (ICF).
Subject is ? 18 years of age at the time of signing the informed consent form (ICF).
Subject is considered an adult according to local regulation at the time of obtaining consent form (ICF).