Able to undergo all screening assessments outlined in the protocol.
Any uncontrollable intercurrent illness, infection, or other conditions that could limit study compliance or interfere with assessments.
Lack of availability for follow up assessments
Able to understand and willing to complete symptom assessments using a patient reported outcomes instrument
Lack of availability for follow up assessments
Lack of availability of study subject for immunological and clinical follow up assessments
Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment and would interfere with follow-up assessments through year 5
Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Patients (female or male) must provide informed written consent and must complete all screening assessments as outlined in the protocol
Inability to complete neurocognitive assessments per investigator discretion
Current or recurrent disease that could affect the action or disposition of IT-141, or clinical or laboratory assessments.
Patients must complete all screening assessments as outlined in the protocol
Patients must complete all screening assessments
Geographical accessibility and willingness to return to FCCC for all preoperative and postoperative study assessments
Any conditions that would preclude a patient from completing all study assessments
Willing to return for all required study assessments
Screening laboratory assessments:
Adequate baseline laboratory assessments
Adequate baseline laboratory assessments
Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival.
Be willing to complete Quality of Life assessments during the study
Notes: subjects may not have had a transfusion within 7 days of screening assessments; concomitant elevation of bilirubin and AST/ALT above the IULN is not allowed
Patients must have at least one metastatic lesion that can be followed on baseline imaging obtained no more than 28 days prior to beginning study therapy. Baseline and follow up radiological disease assessments must include bone scans performed with 99mTc labelled diphosphonates
Lack of availability for immunological and clinical follow-up assessments.
Satisfactory completion of dosing & efficacy assessments in ISIS 420915-CS2
Lack of availability for immunological and clinical assessments or post-study follow-up contact to determine relapse and survival
Completion of screening and baseline assessments
Acceptable laboratory assessments obtained within 14 days prior to Randomization
Adequate baseline laboratory assessments, including
Lack of availability for immunological and clinical follow-up assessments.
Patients must complete all screening assessments as outlined in the protocol
Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject's ability to safely receive treatment or complete study assessments
Adequate baseline laboratory assessments
Grade 3 or 4 eye disorder at study entry, unless stable and longstanding (>3 months) and unlikely to interfere with protocol-required ophthalmology assessments.
Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
Lack of availability for immunological and clinical follow-up assessments.
Completion of screening assessments (Refer to protocol for further details)
Adequate baseline laboratory assessments, including:
Adequate baseline laboratory assessments
Willingness to participate in Patient-Reported Outcomes assessments
Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments
Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
Willingness and ability to participate in study assessments and the eight-week intervention
Able to complete study assessments, including keeping a daily diary
In the judgment of investigators/consenting professionals, able to comprehend English to complete study assessments
Able to complete study assessments
Able to complete study assessments
Cognitively able to complete assessments as judged by the study team
Patients who are able to complete the assessments
Other injury or condition that prevents ambulation or completion of study assessments
Able to complete study assessments
Able to complete study assessments
Ability to complete the 4 or 6 weeks of acupuncture and follow-up assessments
English insufficient to complete baseline patient-reported outcomes (PRO) assessments
Willingness to comply with all study interventions of acupuncture and follow-up assessments
Patients must complete all pre-entry assessments
PHASE II: Able to complete all study assessments and procedures in English
Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
FOLLOW-UP ASSESSMENTS:
FOLLOW-UP ASSESSMENTS: Must be non-adherent for CRC screening at the time of the educational program
FOLLOW-UP ASSESSMENTS: Self-identify as African American
FOLLOW-UP ASSESSMENTS: Agree to providing consent for release/review of their medical record
With evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
Lack of availability for follow-up assessments
Any condition conflict based on the investigation’s clinical judgment that would prevent the patient from completion all trial assessments and visits
Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
Subjects must complete all baseline screening assessments
Willingness to provide multiple contacts (i.e., phone numbers, addresses of close others) if not reached for follow-up assessments
Be willing and capable of completing the assessments and adhering to protocol requirements.