ID

34888

Description

A Study of HMPL-523 in Relapsed or Refractory B-cell Non-Hodgkin's Lymphomas or Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT02503033

Link

https://clinicaltrials.gov/show/NCT02503033

Keywords

Versions (1)
  1. 2/2/19 2/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility B-cell Non-Hodgkin's Lymphomas NCT02503033

English

Eligibility B-cell Non-Hodgkin's Lymphomas NCT02503033

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent form
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. ability to comply with the protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
3. age ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. histologically relapsed and/or refractory b-cell non-hodgkin's lymphomas or chronic lymphocytic leukemia
Description

Recurrent B-Cell Non-Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0855089
UMLS CUI [2]
C0855090
UMLS CUI [3]
C0023434
in the dose expansion stage, the tumor types are restricted to relapsed and/or refractory cll/sll, mcl, fl, dlbcl and wm.
Description

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | B-cell small lymphocytic lymphoma recurrent | B-cell small lymphocytic lymphoma refractory | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Waldenstrom's macroglobulinaemia recurrent | Waldenstrom Macroglobulinemia refractory

Data type

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2]
C0278791
UMLS CUI [3]
C0855096
UMLS CUI [4]
C0855097
UMLS CUI [5]
C0677725
UMLS CUI [6]
C0855138
UMLS CUI [7]
C1335701
UMLS CUI [8]
C1335723
UMLS CUI [9]
C0855111
UMLS CUI [10]
C0855112
UMLS CUI [11]
C0853709
UMLS CUI [12,1]
C0024419
UMLS CUI [12,2]
C0205269
6. have failed at least one prior therapy or patients who are unable to tolerate standard therapy or no curative therapy or therapy of higher priority exists
Description

Prior Therapy Quantity failed | Standard therapy Receive Unable | Curative treatment Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0332268
7. in the dose-expansion stage, patients must have measurable disease for objective response assessment.
Description

Measurable Disease Response Assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C3889269
8. expected survival of more than 24 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
9. male or female patients of child-bearing potential must agree to use double barrier contraception, condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud), contraceptives (oral or parenteral), implanon, injectables or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment. post-menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
Description

Females & males of reproductive potential Barrier Contraception Double | Condoms | Contraceptive Sponge | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Implanon | Injectable contraception | Contraceptive methods | Exception Postmenopausal state | Exception Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
UMLS CUI [2]
C0677582
UMLS CUI [3]
C0183461
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0009905
UMLS CUI [7]
C0673606
UMLS CUI [8]
C1262153
UMLS CUI [9]
C0700589
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0232970
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0015787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with t-cell lymphoma or primary cns lymphoma
Description

T-Cell Lymphoma | Primary central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079772
UMLS CUI [2]
C0280803
2. known active central nervous system or leptomeningeal lymphoma
Description

Central nervous system lymphoma | Meningeal Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
UMLS CUI [2]
C2213017
3. any of the following laboratory abnormalities:
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
absolute neutrophil count<1.5×109/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
hemoglobin <80g/l
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
platelet<75 ×109 /l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
4. inadequate organ function, defined by the following:
Description

Organ function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
total bilirubin >1.5the uln with the following exception:
Description

Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0741494
patients with known gilbert disease who have serum bilirubin level ≤3 the uln and normal ast/alt may be enrolled.
Description

Exception | Gilbert Disease | Elevated total bilirubin | Aspartate aminotransferase normal | Alanine aminotransferase normal

Data type

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2]
C0017551
UMLS CUI [3]
C0741494
UMLS CUI [4]
C0855624
UMLS CUI [5]
C0855620
ast and/or alt > 2.5 the uln with the following exception:patients with documented disease infiltration of the liver may have ast and/or alt levels ≤ 5 the uln.
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception | Disease Infiltration Liver | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C1705847
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332448
UMLS CUI [4,3]
C0023884
UMLS CUI [5]
C0151904
UMLS CUI [6]
C0151905
serum creatinine > 1.5 the uln or estimated creatinine clearance < 50 ml/min
Description

Serum creatinine raised | Estimation of creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C2711451
serum amylase or lipase > the uln
Description

Serum amylase raised | Serum lipase raised

Data type

boolean

Alias
UMLS CUI [1]
C0476327
UMLS CUI [2]
C3670924
triglycerides and/or cholesterol >1.5 the uln
Description

Hypertriglyceridemia | Increased cholesterol

Data type

boolean

Alias
UMLS CUI [1]
C0020557
UMLS CUI [2]
C3276464
international normalized ratio (inr)>1.5 the uln or activated partial thromboplastin time (aptt)>1.5 the uln
Description

INR raised | aPTT prolonged

Data type

boolean

Alias
UMLS CUI [1]
C0853225
UMLS CUI [2]
C0240671
5. subjects with presence of clinically detectable second primary malignant tumors at enrollment, or other malignant tumors within the last 2 years (with the exception of radically treated basal cell or squamous cell carcinoma of the skin, in situ cervix, or in situ breast cancer).
Description

Second Primary Cancers | Cancer Other | Exception Basal cell carcinoma Treated Radical | Exception Squamous cell carcinoma of skin Treated Radical | Exception Carcinoma in situ of uterine cervix Treated Radical | Exception Carcinoma in situ of female breast Treated Radical

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C1707251
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C0439807
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [4,4]
C0439807
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [5,4]
C0439807
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0686288
UMLS CUI [6,3]
C1522326
UMLS CUI [6,4]
C0439807
6. any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment
Description

Cancer treatment | Chemotherapy | Hormone Therapy | Biological treatment | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0279025
UMLS CUI [4]
C1531518
UMLS CUI [5]
C1522449
7. herbal therapy ≤1 week prior to initiation of study treatment
Description

Phytotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0242388
8. prior use of any anti-cancer vaccine
Description

Cancer Vaccines

Data type

boolean

Alias
UMLS CUI [1]
C0376659
9. prior treatment with any syk inhibitors (fostamatinib)
Description

SYK inhibitors | fostamatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0134982
UMLS CUI [1,2]
C0243077
UMLS CUI [2]
C2713632
10. prior administration of radioimmunotherapy 3 months prior to initiation of study treatment
Description

Radioimmunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0085101
11. adverse events from prior anti-cancer therapy that have not resolved to grade ≤1, except for alopecia
Description

Adverse event Due to Cancer treatment | Lacking Resolution CTCAE Grades | Exception Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920425
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C1514893
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
12. prior autologous transplant within 6 months prior to first dose of study drug
Description

Transplantation, Autologous

Data type

boolean

Alias
UMLS CUI [1]
C0040736
13. prior allogeneic stem cell transplant within 6 months prior to initiation of study treatment or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to initiation of study treatment
Description

Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Patient need for Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2]
C0018133
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0021081
14. clinically significant active infection (pneumonia)
Description

Communicable Disease | Pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0032285
15. major surgical procedure within 4 weeks prior to initiation of study treatment
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
16. clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus (hbv), or hepatitis c virus (hcv)
Description

Liver disease | Liver Cirrhosis | Alcohol abuse | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
17. pregnant (positive pregnancy test) or lactating women
Description

Pregnancy | Pregnancy test positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
18. new york heart association (nyha) class ii or greater congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
19. congenital long qt syndrome or qtc > 450 msec
Description

Congenital long QT syndrome | Prolonged QTc

Data type

boolean

Alias
UMLS CUI [1]
C1141890
UMLS CUI [2]
C1969409
20. currently use medication known to cause qt prolongation.
Description

Pharmaceutical Preparations Causing Prolonged QT interval

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
21. history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
Description

Myocardial Infarction | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
22. history of stroke or transient ischemic attack within 6 months prior to initiation of study treatment
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
23. image evidence of gallstone or other bile duct disease within 6 months prior to initiation of study treatment
Description

Cholelithiasis Imaging | Bile Duct Disease Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0008350
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0005395
UMLS CUI [2,2]
C0011923
24. inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
Description

Lacking Able to take medication Oral | Operative Surgical Procedures Affecting Absorption | Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C4075001
UMLS CUI [1,3]
C1527415
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0237442
UMLS CUI [3]
C0030920
25. treatment within a clinical study within 30 days prior to initiation of study treatment
Description

Study Subject Participation Status | Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0087111
26. any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
Description

Comorbidity | Dysfunction Metabolic | Physical Examination | Laboratory test finding | Medical contraindication Investigational New Drugs | Condition Affecting Interpretation Research results | Condition High risk Complications of treatment

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0311400
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0587081
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0013230
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C4319571
UMLS CUI [7,3]
C0679861
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Similar models

Eligibility B-cell Non-Hodgkin's Lymphomas NCT02503033

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
2. ability to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Age
Item
3. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Recurrent B-Cell Non-Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Chronic Lymphocytic Leukemia
Item
5. histologically relapsed and/or refractory b-cell non-hodgkin's lymphomas or chronic lymphocytic leukemia
boolean
C0855089 (UMLS CUI [1])
C0855090 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | B-cell small lymphocytic lymphoma recurrent | B-cell small lymphocytic lymphoma refractory | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Waldenstrom's macroglobulinaemia recurrent | Waldenstrom Macroglobulinemia refractory
Item
in the dose expansion stage, the tumor types are restricted to relapsed and/or refractory cll/sll, mcl, fl, dlbcl and wm.
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C0855096 (UMLS CUI [3])
C0855097 (UMLS CUI [4])
C0677725 (UMLS CUI [5])
C0855138 (UMLS CUI [6])
C1335701 (UMLS CUI [7])
C1335723 (UMLS CUI [8])
C0855111 (UMLS CUI [9])
C0855112 (UMLS CUI [10])
C0853709 (UMLS CUI [11])
C0024419 (UMLS CUI [12,1])
C0205269 (UMLS CUI [12,2])
Prior Therapy Quantity failed | Standard therapy Receive Unable | Curative treatment Lacking
Item
6. have failed at least one prior therapy or patients who are unable to tolerate standard therapy or no curative therapy or therapy of higher priority exists
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C2936643 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C1273390 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Measurable Disease Response Assessment
Item
7. in the dose-expansion stage, patients must have measurable disease for objective response assessment.
boolean
C1513041 (UMLS CUI [1,1])
C3889269 (UMLS CUI [1,2])
Life Expectancy
Item
8. expected survival of more than 24 weeks
boolean
C0023671 (UMLS CUI [1])
Females & males of reproductive potential Barrier Contraception Double | Condoms | Contraceptive Sponge | Vaginal contraceptive diaphragm | Intrauterine Devices | Contraceptives, Oral | Implanon | Injectable contraception | Contraceptive methods | Exception Postmenopausal state | Exception Female Sterilization
Item
9. male or female patients of child-bearing potential must agree to use double barrier contraception, condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud), contraceptives (oral or parenteral), implanon, injectables or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment. post-menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
boolean
C4034483 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0677582 (UMLS CUI [2])
C0183461 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0673606 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0700589 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0232970 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0015787 (UMLS CUI [11,2])
Item Group
C0680251 (UMLS CUI)
T-Cell Lymphoma | Primary central nervous system lymphoma
Item
1. patients with t-cell lymphoma or primary cns lymphoma
boolean
C0079772 (UMLS CUI [1])
C0280803 (UMLS CUI [2])
Central nervous system lymphoma | Meningeal Lymphoma
Item
2. known active central nervous system or leptomeningeal lymphoma
boolean
C0742472 (UMLS CUI [1])
C2213017 (UMLS CUI [2])
Laboratory test result abnormal
Item
3. any of the following laboratory abnormalities:
boolean
C0438215 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count<1.5×109/l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin <80g/l
boolean
C0518015 (UMLS CUI [1])
Platelet Count measurement
Item
platelet<75 ×109 /l
boolean
C0032181 (UMLS CUI [1])
Organ function Inadequate
Item
4. inadequate organ function, defined by the following:
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Elevated total bilirubin
Item
total bilirubin >1.5the uln with the following exception:
boolean
C0741494 (UMLS CUI [1])
Exception | Gilbert Disease | Elevated total bilirubin | Aspartate aminotransferase normal | Alanine aminotransferase normal
Item
patients with known gilbert disease who have serum bilirubin level ≤3 the uln and normal ast/alt may be enrolled.
boolean
C1705847 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C0741494 (UMLS CUI [3])
C0855624 (UMLS CUI [4])
C0855620 (UMLS CUI [5])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception | Disease Infiltration Liver | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast and/or alt > 2.5 the uln with the following exception:patients with documented disease infiltration of the liver may have ast and/or alt levels ≤ 5 the uln.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C1705847 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0332448 (UMLS CUI [4,2])
C0023884 (UMLS CUI [4,3])
C0151904 (UMLS CUI [5])
C0151905 (UMLS CUI [6])
Serum creatinine raised | Estimation of creatinine clearance
Item
serum creatinine > 1.5 the uln or estimated creatinine clearance < 50 ml/min
boolean
C0700225 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum amylase raised | Serum lipase raised
Item
serum amylase or lipase > the uln
boolean
C0476327 (UMLS CUI [1])
C3670924 (UMLS CUI [2])
Hypertriglyceridemia | Increased cholesterol
Item
triglycerides and/or cholesterol >1.5 the uln
boolean
C0020557 (UMLS CUI [1])
C3276464 (UMLS CUI [2])
INR raised | aPTT prolonged
Item
international normalized ratio (inr)>1.5 the uln or activated partial thromboplastin time (aptt)>1.5 the uln
boolean
C0853225 (UMLS CUI [1])
C0240671 (UMLS CUI [2])
Second Primary Cancers | Cancer Other | Exception Basal cell carcinoma Treated Radical | Exception Squamous cell carcinoma of skin Treated Radical | Exception Carcinoma in situ of uterine cervix Treated Radical | Exception Carcinoma in situ of female breast Treated Radical
Item
5. subjects with presence of clinically detectable second primary malignant tumors at enrollment, or other malignant tumors within the last 2 years (with the exception of radically treated basal cell or squamous cell carcinoma of the skin, in situ cervix, or in situ breast cancer).
boolean
C0751623 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0439807 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C0439807 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C0439807 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0686288 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C0439807 (UMLS CUI [6,4])
Cancer treatment | Chemotherapy | Hormone Therapy | Biological treatment | Therapeutic radiology procedure
Item
6. any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy within 3 weeks prior to initiation of study treatment
boolean
C0920425 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Phytotherapy
Item
7. herbal therapy ≤1 week prior to initiation of study treatment
boolean
C0242388 (UMLS CUI [1])
Cancer Vaccines
Item
8. prior use of any anti-cancer vaccine
boolean
C0376659 (UMLS CUI [1])
SYK inhibitors | fostamatinib
Item
9. prior treatment with any syk inhibitors (fostamatinib)
boolean
C0134982 (UMLS CUI [1,1])
C0243077 (UMLS CUI [1,2])
C2713632 (UMLS CUI [2])
Radioimmunotherapy
Item
10. prior administration of radioimmunotherapy 3 months prior to initiation of study treatment
boolean
C0085101 (UMLS CUI [1])
Adverse event Due to Cancer treatment | Lacking Resolution CTCAE Grades | Exception Alopecia
Item
11. adverse events from prior anti-cancer therapy that have not resolved to grade ≤1, except for alopecia
boolean
C0877248 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
Transplantation, Autologous
Item
12. prior autologous transplant within 6 months prior to first dose of study drug
boolean
C0040736 (UMLS CUI [1])
Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Patient need for Immunosuppressive Agents
Item
13. prior allogeneic stem cell transplant within 6 months prior to initiation of study treatment or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to initiation of study treatment
boolean
C4255274 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0021081 (UMLS CUI [3,2])
Communicable Disease | Pneumonia
Item
14. clinically significant active infection (pneumonia)
boolean
C0009450 (UMLS CUI [1])
C0032285 (UMLS CUI [2])
Major surgery
Item
15. major surgical procedure within 4 weeks prior to initiation of study treatment
boolean
C0679637 (UMLS CUI [1])
Liver disease | Liver Cirrhosis | Alcohol abuse | HIV Infection | Hepatitis B | Hepatitis C
Item
16. clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus (hbv), or hepatitis c virus (hcv)
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
Pregnancy | Pregnancy test positive | Breast Feeding
Item
17. pregnant (positive pregnancy test) or lactating women
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
18. new york heart association (nyha) class ii or greater congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Congenital long QT syndrome | Prolonged QTc
Item
19. congenital long qt syndrome or qtc > 450 msec
boolean
C1141890 (UMLS CUI [1])
C1969409 (UMLS CUI [2])
Pharmaceutical Preparations Causing Prolonged QT interval
Item
20. currently use medication known to cause qt prolongation.
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
Myocardial Infarction | Angina, Unstable
Item
21. history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
22. history of stroke or transient ischemic attack within 6 months prior to initiation of study treatment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Cholelithiasis Imaging | Bile Duct Disease Imaging
Item
23. image evidence of gallstone or other bile duct disease within 6 months prior to initiation of study treatment
boolean
C0008350 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0005395 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Lacking Able to take medication Oral | Operative Surgical Procedures Affecting Absorption | Peptic Ulcer
Item
24. inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
boolean
C0332268 (UMLS CUI [1,1])
C4075001 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0030920 (UMLS CUI [3])
Study Subject Participation Status | Therapeutic procedure
Item
25. treatment within a clinical study within 30 days prior to initiation of study treatment
boolean
C2348568 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Comorbidity | Dysfunction Metabolic | Physical Examination | Laboratory test finding | Medical contraindication Investigational New Drugs | Condition Affecting Interpretation Research results | Condition High risk Complications of treatment
Item
26. any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
boolean
C0009488 (UMLS CUI [1])
C3887504 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])
C0587081 (UMLS CUI [4])
C1301624 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C0348080 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0348080 (UMLS CUI [7,1])
C4319571 (UMLS CUI [7,2])
C0679861 (UMLS CUI [7,3])
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