Malignant lymphoid neoplasm Relapse | Malignant lymphoid neoplasm refractory | Standard of Care Unavailable | Standard of Care ineffective
Item
part 1 (dose exploration): relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective:
boolean
C0746336 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0746336 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C3242229 (UMLS CUI [4,2])
Chronic Lymphocytic Leukemia Immunophenotyping | Lymphoma, Non-Hodgkin | B-Cell Lymphoma low grade | B-Cell Lymphoma Intermediate Grade | Mantle cell lymphoma | T-Cell Lymphoma
Item
b-cell chronic lymphocytic leukemia (cll) confirmed by immunophenotype or non-hodgkin lymphoma: low or intermediate grade b-cell nhl, mantle cell lymphoma, non-cutaneous t-cell nhl confirmed by histology and/or immunophenotype
boolean
C0023434 (UMLS CUI [1,1])
C0079611 (UMLS CUI [1,2])
C0024305 (UMLS CUI [2])
C0079731 (UMLS CUI [3,1])
C1282907 (UMLS CUI [3,2])
C0079731 (UMLS CUI [4,1])
C1512863 (UMLS CUI [4,2])
C0334634 (UMLS CUI [5])
C0079772 (UMLS CUI [6])
Recurrent Chronic Lymphoid Leukemia Immunophenotyping | Chronic lymphocytic leukaemia refractory Immunophenotyping | Standard of Care Unavailable | Standard of Care ineffective
Item
part 2 (dose expansion): subjects must have relapsed or refractory b-cell chronic lymphocytic leukemia confirmed by immunophenotype for which standard treatment does not exist or is no longer effective.
boolean
C0854802 (UMLS CUI [1,1])
C0079611 (UMLS CUI [1,2])
C0278791 (UMLS CUI [2,1])
C0079611 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C3242229 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of > 3 months, in the opinion of the investigator
boolean
C0023671 (UMLS CUI [1])
Age
Item
men or women ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Hematologic function
Item
hematological function, as follows:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count | Exception Bone Marrow Involvement | Platelet Count measurement | Transfusion Absent | Hemoglobin measurement
Item
absolute neutrophil count (anc) ≥ 1.5 x 109/l (unless due to disease-related bone marrow involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/l) platelet count ≥ 50 x 109/l (without a transfusion within 14 days before enrollment) hemoglobin ≥ 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C1879316 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0518015 (UMLS CUI [5])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Etiology Extrahepatic | Serum total bilirubin measurement | Gilbert Disease | Serum indirect bilirubin measurement | Amylase measurement | Lipase measurement
Item
hepatic function, as follows: aspartate aminotransferase (ast) < 3.0 x uln alanine aminotransferase (alt) < 3.0 x uln alkaline phosphatase (alp) < 2.0 x uln (< 5 x uln in subjects whom the pi and sponsor agree that clinical data suggest an extrahepatic source of elevation) total bilirubin < 1.5 x uln (< 3.0 x uln for subjects with documented gilbert's disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation) amylase ≤ 2.0 x iuln lipase ≤ 2.0 x iuln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0015127 (UMLS CUI [5,1])
C1517058 (UMLS CUI [5,2])
C1278039 (UMLS CUI [6])
C0017551 (UMLS CUI [7])
C2229600 (UMLS CUI [8])
C0201883 (UMLS CUI [9])
C0373670 (UMLS CUI [10])
Primary tumor Central Nervous System Involvement | Disseminated Malignant Neoplasm Central Nervous System Involvement
Item
primary or disseminated tumor involving the central nervous system (cns)
boolean
C0677930 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
C0346957 (UMLS CUI [2,1])
C4050309 (UMLS CUI [2,2])
Cancer Other | Exception Skin carcinoma Treated | Exception Curative treatment In situ cancer | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851135 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Allogeneic Stem Cell Transplantation | Organ Transplantation
Item
history of allogeneic stem-cell (or other organ) transplantation
boolean
C2242529 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Electrocardiographic changes Interfere with P-R interval | Electrocardiographic changes Interfere with QT interval | Electrocardiographic changes Interfere with QRS interval | Congenital long QT syndrome
Item
clinically significant ecg changes which obscure the ability to assess the pr, qt, and qrs interval; congenital long qt syndrome
boolean
C0855329 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,3])
C0855329 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0429028 (UMLS CUI [2,3])
C0855329 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2168881 (UMLS CUI [3,3])
C1141890 (UMLS CUI [4])
QTcF - Fridericia's Correction Formula
Item
qtcf interval > 470 msec
boolean
C1882513 (UMLS CUI [1])
Hepatitis B Serologic tests | Chronic Hepatitis B Serologic tests | Hepatitis C Serologic tests | Chronic Hepatitis C Serologic tests
Item
active or chronic hepatitis b or hepatitis c infection, determined by serologic tests
boolean
C0019163 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
C0524910 (UMLS CUI [4,1])
C0036743 (UMLS CUI [4,2])
Communicable Disease Recent | Requirement Anti-infective therapy Intravenous | Anti-infective therapy Completed
Item
recent infection requiring intravenous anti-infective treatment that was completed ≤
boolean
C0009450 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1141958 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C1141958 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
ID.17
Item
14 days before enrollment
boolean