ID

37713

Beskrivning

Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT02206308

Länk

https://clinicaltrials.gov/show/NCT02206308

Nyckelord

Versioner (1)
  1. 2019-08-19 2019-08-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 augusti 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

Engelsk

Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged from 18 to 75 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
having histologically confirmed nhl expressing cd20 antigen
Beskrivning

Non-Hodgkin Lymphoma CD20 Expressing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C3888518
having relapsed non-hodgkin's lymphoma(nhl) after at least one prior course of standard therapy
Beskrivning

Recurrent Adult Non-Hodgkin Lymphoma | Status post Course Quantity Standard therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279999
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C2936643
eastern cooperative oncology group (ecog) performance status ≤ 2 according to who scale, and expected survival of at least ≥ 3 months
Beskrivning

ECOG performance status | WHO performance status scale | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1298650
UMLS CUI [3]
C0023671
signed an informed consent form which was approved by the institutional review board of the respective medical center
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
single measurable lesion ≥7 cm in diameter
Beskrivning

Measurable lesion Single Diameter

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C1301886
with serious hematologic dysfunction (white blood cell count of <3.0×103/μl; absolute neutrophil count of <1.5×103/ μl; platelet count of < 75×103/μl; hemoglobin level of < 8.0 g/dl; serum immunoglobulin g(igg) level of <600 mg/dl);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（uln）; aspartate amino transferase (ast) and alanine amino transferase (alt) levels of >2.5 × uln (≥5 × uln for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×uln )
Beskrivning

Dysfunction Hematologic Serious | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Immunoglobulin G measurement | Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver | Renal dysfunction | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3887504
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0202087
UMLS CUI [7]
C0086565
UMLS CUI [8]
C0741494
UMLS CUI [9]
C0151904
UMLS CUI [10]
C0151905
UMLS CUI [11,1]
C0439849
UMLS CUI [11,2]
C0494165
UMLS CUI [12]
C3279454
UMLS CUI [13]
C0201976
having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
Beskrivning

Cancer treatment Previous | Adrenal Cortex Hormones | Study Subject Participation Status | Toxicity Due to Prior Therapy | Recovery Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0001617
UMLS CUI [3]
C2348568
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1514463
UMLS CUI [5,1]
C2004454
UMLS CUI [5,2]
C0332268
had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 year before enrollment
Beskrivning

rituximab | Anti-CD20 Antibody

Datatyp

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C3891557
had received hematopoietic cytokines, e.g csf、epo within 1 week prior to study entry
Beskrivning

Hematopoietic Cell Growth Factors | Colony-Stimulating Factors | Erythropoietin

Datatyp

boolean

Alias
UMLS CUI [1]
C0079490
UMLS CUI [2]
C0009392
UMLS CUI [3]
C0014822
with other malignancies ; or central nervous system (cns) lymphoma, aids- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
Beskrivning

Cancer Other | Central nervous system lymphoma | Lymphoma, AIDS-Related | Opportunistic Infection | Disease Non-Malignant Serious

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2]
C0742472
UMLS CUI [3]
C0085090
UMLS CUI [4]
C0029118
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1518371
UMLS CUI [5,3]
C0205404
having hepatitis b virus surface antigen and /or antibodies to hepatitis c virus or human immunodeficiency virus
Beskrivning

Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV

Datatyp

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019682
with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
Beskrivning

Pleural effusions Secondary to Lymphoma | Ascites Secondary to Lymphoma | High risk of Tumor Lysis Syndrome | Major surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C0003962
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0024299
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0041364
UMLS CUI [4]
C0679637
with a history of allergic reaction or protein product allergy including murine proteins
Beskrivning

Allergic Reaction Proteins | Protein allergy | Allergic Reaction Murine protein | Hypersensitivity Murine protein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0033684
UMLS CUI [2]
C1112677
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1699668
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1699668
pregnant or lactating or not accepted birth control methods including male patients
Beskrivning

Pregnancy | Breast Feeding | Contraceptive methods Rejected | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1548437
UMLS CUI [4]
C0079399
Tillbaka till toppen

Similar models

Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged from 18 to 75 years
boolean
C0001779 (UMLS CUI [1])
Non-Hodgkin Lymphoma CD20 Expressing
Item
having histologically confirmed nhl expressing cd20 antigen
boolean
C0024305 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
Recurrent Adult Non-Hodgkin Lymphoma | Status post Course Quantity Standard therapy
Item
having relapsed non-hodgkin's lymphoma(nhl) after at least one prior course of standard therapy
boolean
C0279999 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2936643 (UMLS CUI [2,4])
ECOG performance status | WHO performance status scale | Life Expectancy
Item
eastern cooperative oncology group (ecog) performance status ≤ 2 according to who scale, and expected survival of at least ≥ 3 months
boolean
C1520224 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Informed Consent
Item
signed an informed consent form which was approved by the institutional review board of the respective medical center
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Measurable lesion Single Diameter
Item
single measurable lesion ≥7 cm in diameter
boolean
C1513041 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Dysfunction Hematologic Serious | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Immunoglobulin G measurement | Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver | Renal dysfunction | Creatinine measurement, serum
Item
with serious hematologic dysfunction (white blood cell count of <3.0×103/μl; absolute neutrophil count of <1.5×103/ μl; platelet count of < 75×103/μl; hemoglobin level of < 8.0 g/dl; serum immunoglobulin g(igg) level of <600 mg/dl);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（uln）; aspartate amino transferase (ast) and alanine amino transferase (alt) levels of >2.5 × uln (≥5 × uln for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×uln )
boolean
C3887504 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0202087 (UMLS CUI [6])
C0086565 (UMLS CUI [7])
C0741494 (UMLS CUI [8])
C0151904 (UMLS CUI [9])
C0151905 (UMLS CUI [10])
C0439849 (UMLS CUI [11,1])
C0494165 (UMLS CUI [11,2])
C3279454 (UMLS CUI [12])
C0201976 (UMLS CUI [13])
Cancer treatment Previous | Adrenal Cortex Hormones | Study Subject Participation Status | Toxicity Due to Prior Therapy | Recovery Lacking
Item
having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C0600688 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1514463 (UMLS CUI [4,3])
C2004454 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
rituximab | Anti-CD20 Antibody
Item
had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 year before enrollment
boolean
C0393022 (UMLS CUI [1])
C3891557 (UMLS CUI [2])
Hematopoietic Cell Growth Factors | Colony-Stimulating Factors | Erythropoietin
Item
had received hematopoietic cytokines, e.g csf、epo within 1 week prior to study entry
boolean
C0079490 (UMLS CUI [1])
C0009392 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
Cancer Other | Central nervous system lymphoma | Lymphoma, AIDS-Related | Opportunistic Infection | Disease Non-Malignant Serious
Item
with other malignancies ; or central nervous system (cns) lymphoma, aids- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
boolean
C1707251 (UMLS CUI [1])
C0742472 (UMLS CUI [2])
C0085090 (UMLS CUI [3])
C0029118 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C1518371 (UMLS CUI [5,2])
C0205404 (UMLS CUI [5,3])
Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV
Item
having hepatitis b virus surface antigen and /or antibodies to hepatitis c virus or human immunodeficiency virus
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
Pleural effusions Secondary to Lymphoma | Ascites Secondary to Lymphoma | High risk of Tumor Lysis Syndrome | Major surgery
Item
with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
boolean
C0032227 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C0003962 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C0332167 (UMLS CUI [3,1])
C0041364 (UMLS CUI [3,2])
C0679637 (UMLS CUI [4])
Allergic Reaction Proteins | Protein allergy | Allergic Reaction Murine protein | Hypersensitivity Murine protein
Item
with a history of allergic reaction or protein product allergy including murine proteins
boolean
C1527304 (UMLS CUI [1,1])
C0033684 (UMLS CUI [1,2])
C1112677 (UMLS CUI [2])
C1527304 (UMLS CUI [3,1])
C1699668 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1699668 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Contraceptive methods Rejected | Gender
Item
pregnant or lactating or not accepted birth control methods including male patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1548437 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial