ID

15933

Description

Phase I Study of Oral PQR309 in Patients With Relapsed or Refractory Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02249429

Link

https://clinicaltrials.gov/show/NCT02249429

Keywords

Versions (1)
  1. 6/19/16 6/19/16 -
Uploaded on

June 19, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsed or Refractory Lymphomas DRKS00010139 NCT02249429

English

Eligibility Relapsed or Refractory Lymphomas NCT02249429

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of relapsed or refractory lymphoma and received at least one prior line of therapy.
Description

Non-Hodgkin's lymphoma recurrent | Non-Hodgkin's lymphoma refractory | Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0854866
UMLS CUI [2]
C0854867
UMLS CUI [3]
C1514463
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
use of adequate contraceptive measures for male patients.
Description

Male Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0086580
eastern cooperative oncology group (ecog) performance score of 0-1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
signed informed consent.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous allogeneic hematopoietic stem cell transplant (hsct transplant).
Description

Allogeneic Hematopoietic Stem Cell Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1705576
UMLS CUI [1,2]
C0205156
autologous stem cell transplant within the last 6 months.
Description

Transplantation of autologous hematopoietic stem cell

Data type

boolean

Alias
UMLS CUI [1]
C1831743
concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors).
Description

cancer treatment Simultaneous | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Biological Response Modifiers | Signal Transduction Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0521115
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0021083
UMLS CUI [6]
C0005525
UMLS CUI [7]
C1519313
patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
Description

Myocardial Infarction | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure nyha class 3 or 4, hypertension bp>150/100mmhg.
Description

Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | New York Heart Association Classification | Hypertensive disease | Blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0190961
UMLS CUI [5]
C0742758
UMLS CUI [6]
C1275491
UMLS CUI [7]
C0020538
UMLS CUI [8]
C1271104
pre-diagnosed diabetes mellitus.
Description

Diabetes Mellitus | Diagnosis Pre

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0332152
fasting glucose > 7.0 mmol/l or hba1c > 6.4%.
Description

Glucose measurement, fasting | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2]
C0019018
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Similar models

Eligibility Relapsed or Refractory Lymphomas NCT02249429

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin's lymphoma recurrent | Non-Hodgkin's lymphoma refractory | Prior Therapy
Item
histologically confirmed diagnosis of relapsed or refractory lymphoma and received at least one prior line of therapy.
boolean
C0854866 (UMLS CUI [1])
C0854867 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Male Contraception
Item
use of adequate contraceptive measures for male patients.
boolean
C0086580 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance score of 0-1.
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allogeneic Hematopoietic Stem Cell Transplantation Previous
Item
previous allogeneic hematopoietic stem cell transplant (hsct transplant).
boolean
C1705576 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Transplantation of autologous hematopoietic stem cell
Item
autologous stem cell transplant within the last 6 months.
boolean
C1831743 (UMLS CUI [1])
cancer treatment Simultaneous | Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Biological Response Modifiers | Signal Transduction Inhibitor
Item
concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors).
boolean
C0920425 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
C0005525 (UMLS CUI [6])
C1519313 (UMLS CUI [7])
Myocardial Infarction | Coronary Artery Bypass Surgery
Item
patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Angina Pectoris Severe | Angina, Unstable | Coronary Artery Bypass Surgery | Peripheral arterial bypass | Symptomatic congestive heart failure | New York Heart Association Classification | Hypertensive disease | Blood pressure
Item
patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure nyha class 3 or 4, hypertension bp>150/100mmhg.
boolean
C0002962 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C0190961 (UMLS CUI [4])
C0742758 (UMLS CUI [5])
C1275491 (UMLS CUI [6])
C0020538 (UMLS CUI [7])
C1271104 (UMLS CUI [8])
Diabetes Mellitus | Diagnosis Pre
Item
pre-diagnosed diabetes mellitus.
boolean
C0011849 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
Glucose measurement, fasting | Glycosylated hemoglobin A
Item
fasting glucose > 7.0 mmol/l or hba1c > 6.4%.
boolean
C0202045 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
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