[c09aa8]: / clusters / 9knumclustersv2 / clust_2441.txt

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Able to tolerate CPI treatment regimen {if already starte
For the CPI-Treated Expansion Cohort: Subject must have received prior treatment with a CPI in the metastatic setting.
Eligible to receive treatment with a CPI.
Received any prior treatment with a CPI.
No radiotherapy, treatment with cytotoxic agents (except CPI-), treatment with biologic agents or any anti-cancer therapy within the weeks prior to treatment with CPI-; hydroxyurea and oral tyrosine kinase inhibitors being used without grade =< toxicity can be taken until day of therapy; patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment); patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade are eligible, but must be documented as such
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past weeks prior to initiation of CPI- treatment (the use of Hydrea is allowed)
Patients who have received immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Therapy with CPI- prior to participating in this trial
Patients who have received cancer immunotherapy of any type within the past weeks prior to initiation of CPI- treatment; steroid use for management of refractory pain or for contrast induced allergy is allowed
Patients who have received cancer immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Patients who have received radiotherapy, surgery, treatment with cytotoxic agents (except CPI-), treatment with biologic agents, immunotherapy, or any other anti-cancer therapy of any kind, or any other standard or investigational treatment for their cancer, or any other investigational agent for any indication, within the past weeks prior to initiation of CPI- treatment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past weeks prior to initiation of CPI- treatment
Patients who have received immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Patients having received prior radiotherapy, treatment with cytotoxic agents (except CPI-), treatment with biologic agents or any anti-cancer therapy for a non-AML malignancy within the weeks prior to treatment with CPI-, or those who have not fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment)
Patients receiving any other standard or investigational treatment for their cancer with a primary goal of improving survival within the past weeks prior to initiation of CPI- treatment
Systemic anti-cancer treatment or radiotherapy less than weeks before the first dose of CPI-
No radiotherapy, treatment with cytotoxic agents (except CPI-), treatment with biologic agents or any anti-cancer therapy within the weeks prior to treatment with CPI-; hydroxyurea and oral tyrosine kinase inhibitors being used without grade =< toxicity can be taken until day of therapy; patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment); patients with persisting, non-hematologic, non-infectious toxicities from prior treatment =< grade are eligible, but must be documented as such
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past weeks prior to initiation of CPI- treatment (the use of Hydrea is allowed)
Patients who have received immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Part C (CPI-Treated Expansion): Subject must have received prior treatment with a CPI in the metastatic setting
Inclusion Criteria:\n\n Adults (aged ? years)\n\n Histologically confirmed diagnosis of a B-cell lymphoma that has progressed in spite of\n prior treatment, and for which additional effective standard therapy is not available\n\n Eastern Cooperative Oncology Group (ECOG) performance status ? \n\n Adequate hematological, renal, hepatic, and coagulation laboratory assessments\n\n Must give written informed consent to participate in this study before the performance of\n any study-related procedure\n\n Exclusion Criteria:\n\n A primary lymphoma of the central nervous system (CNS) or known lymphomatous involvement of\n the CNS\n\n Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the\n absorption of CPI-, including any unresolved nausea, vomiting, or diarrhea that is\n CTCAE grade >\n\n Treatment with proton pump inhibitors, H antagonists, or antacids\n\n Achlorhydria, either documented or suspected on the basis of an associated disease (e.g.,\n pernicious anemia, atrophic gastritis, or certain gastric surgical procedures)\n\n Impaired cardiac function or clinically significant cardiac diseases, including any of the\n following:\n\n - Acute myocardial infarction or angina pectoris ? months prior to starting study drug\n\n - New York Heart Association Class III or IV congestive heart failure\n\n - QTcF > msec on the screening ECG\n\n Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not\n excluded)\n\n A past medical history of other clinically significant cardiovascular disease (e.g.,\n uncontrolled hypertension, history of labile hypertension or history of poor compliance\n with an antihypertensive regimen)\n\n Any other concurrent severe and/or uncontrolled concomitant medical condition that could\n compromise participation in the study (e.g., clinically significant pulmonary disease,\n clinically significant neurological disorder, active or uncontrolled infection)\n\n Systemic anti-cancer treatment or radiotherapy less than weeks before the first dose of\n CPI \n\n Radioimmunotherapy (e.g., I-tositumomab, Y-ibritumomab tiuxetan) less than weeks\n before the first dose of CPI-\n\n Treatment with an investigational small molecule less than weeks before the first dose of\n CPI-.\n\n Treatment with a therapeutic antibody less than weeks before the first dose of CPI-.\n\n Treatment with medications that are strong inhibitors of CYPA\n\n Treatment with medications that are inducers of CYPA enzymes\n\n Treatment with medications that are known to carry a risk of Torsades de Pointes\n\n Pregnant or lactating women\n\n Women of child bearing potential and men with reproductive potential, if they are unwilling\n to use adequate contraception while on study therapy and for months thereafter\n\n Patients unwilling or unable to comply with this study protocol
Systemic anti-cancer treatment or radiotherapy less than weeks before the first dose of CPI-
Radioimmunotherapy (e.g., I-tositumomab, Y-ibritumomab tiuxetan) less than weeks before the first dose of CPI-
Treatment with a therapeutic antibody less than weeks before the first dose of CPI-. A minimum -week period between the last treatment with a therapeutic antibody and the first dose of CPI- may be permitted in patients with rapidly progressive or aggressive subtypes of lymphoma following discussion with the medical monitor.
No acute toxicities from previous treatment higher than grade at the start of treatment with CPI-
Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past weeks prior to initiation of CPI- treatment
Treatment with any anti-cancer therapy within the weeks prior to treatment with CPI-
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past weeks prior to initiation of CPI- (,-bis[benzylthio]octanoic acid) treatment
Patients who have received cancer immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past weeks prior to initiation of CPI- treatment
Patients who have received cancer immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Patients who have received cancer immunotherapy of any type within the past weeks prior to initiation of CPI- treatment
Systemic anti-cancer treatment or radiotherapy less than weeks before the first dose of CPI-
Treatment with a therapeutic antibody less than weeks before the first dose of CPI-. A minimum -week period between the last treatment with a therapeutic antibody and the first dose of CPI- may be permitted in patients with rapidly progressive myeloma, following discussion with the medical monitor
Administration of a therapeutic antibody less than weeks before the first dose of CPI-. A minimum -week period between the last treatment with a therapeutic antibody and the first dose of CPI- may be permitted in patients with rapidly progressive disease, following discussion with the medical monitor