ID

37713

Description

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

Link

https://clinicaltrials.gov/show/NCT02206308

Keywords

Versions (1)
  1. 8/19/19 8/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

English

Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged from 18 to 75 years
Description

Age

Data type

boolean

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

Non-Hodgkin Lymphoma CD20 Expressing

Data type

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
Description

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

Data type

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
Description

ECOG performance status | WHO performance status scale | Life Expectancy

Data type

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
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Measurable lesion Single Diameter

Data type

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 )
Description

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

Data type

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
Description

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

Data type

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
Description

rituximab | Anti-CD20 Antibody

Data type

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
Description

Hematopoietic Cell Growth Factors | Colony-Stimulating Factors | Erythropoietin

Data type

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
Description

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

Data type

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
Description

Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV

Data type

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 )
Description

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

Data type

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
Description

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

Data type

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
Description

Pregnancy | Breast Feeding | Contraceptive methods Rejected | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1548437
UMLS CUI [4]
C0079399
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Similar models

Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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