Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Myelosuppressive Therapy Quantity | Chemotherapy Regimen Quantity | FCR Regimen Scheduled | Bendamustine/rituximab Scheduled
Item
must have relapsed or refractory chronic lymphocytic leukemia (cll), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either fludarabine/cyclophosphamide/rituximab (fcr) or bendamustine/rituximab (br);
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C1513793 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1880650 (UMLS CUI [5,1])
C0205539 (UMLS CUI [5,2])
C1328232 (UMLS CUI [6,1])
C0205539 (UMLS CUI [6,2])
ECOG performance status
Item
subject has an eastern cooperative oncology group (ecog) performance score of </=1;
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Independent of Growth Factor Support | Exception Bone Marrow Infiltration Percentage Comorbidity | Absolute neutrophil count | Platelet Count measurement | Platelet Count measurement Independent of Transfusion | Hemoglobin measurement
Item
must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve absolute neutrophil count (anc) eligibility criteria), per local laboratory reference range at screening as follows: anc >/=1000/mcl, platelets>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of screening),hemoglobin >/= 9.0 g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0018284 (UMLS CUI [1,3])
C1521721 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C0009488 (UMLS CUI [2,5])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0032181 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C1879316 (UMLS CUI [5,3])
C0518015 (UMLS CUI [6])
CNS disorder Relationship Malignant Neoplasm
Item
subject has history or is clinically suspicious for cancer-related central nervous system disease;
boolean
C0007682 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
Allergic Reaction Severe Human Monoclonal Antibodies | Allergic Reaction Severe Humanized Monoclonal Antibodies | Allergic Reaction Severe Chimeric monoclonal antibody | Allergic Reaction Severe Murine Monoclonal Antibodies | Anaphylactic reaction Severe Human Monoclonal Antibodies | Anaphylactic reaction Severe Humanized Monoclonal Antibodies | Anaphylactic reaction Severe Chimeric monoclonal antibody | Anaphylactic reaction Severe Murine Monoclonal Antibodies
Item
has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
C0086418 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2985546 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0598622 (UMLS CUI [3,3])
C0746619 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C2916903 (UMLS CUI [4,3])
C0002792 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0003250 (UMLS CUI [5,3])
C0086418 (UMLS CUI [5,4])
C0002792 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2985546 (UMLS CUI [6,3])
C0002792 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0598622 (UMLS CUI [7,3])
C0746619 (UMLS CUI [7,4])
C0002792 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C2916903 (UMLS CUI [8,3])
Allogeneic Stem Cell Transplantation | Condition Uncontrolled | Sepsis Uncontrolled | Fever | Neutropenia
Item
has undergone an allogeneic stem cell transplant; exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
boolean
C2242529 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0243026 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0015967 (UMLS CUI [4])
C0027947 (UMLS CUI [5])
Bleeding tendency | Signs Hemorrhage | Hemorrhage Associated with Thrombocytopenia | Chemotherapy Absent
Item
has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
boolean
C1458140 (UMLS CUI [1])
C0220912 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0019080 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0040034 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Anticoagulation Therapy
Item
currently receiving or requires anticoagulation therapy;
boolean
C0003281 (UMLS CUI [1])
Immune thrombocytopenic purpura | Platelet Transfusion Unresponsive to Treatment
Item
has active immune thrombocytopenic purpura (itp) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
boolean
C0398650 (UMLS CUI [1])
C0086818 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Peptic Ulcer | Hemorrhagic esophagitis | Hemorrhagic gastritis
Item
has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
boolean
C0030920 (UMLS CUI [1])
C0520560 (UMLS CUI [2])
C2010560 (UMLS CUI [3])