0 Avaliações
ID

37713

Descrição

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

Palavras-chave

Versões (1)
  1. 19/08/2019 19/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de agosto de 2019

DOI

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Licença

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

    Inglês

    Eligibility B-cell Non Hodgkin's Lymphoma NCT02206308

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aged from 18 to 75 years
    Descrição

    Age

    Tipo de dados

    boolean

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

    Non-Hodgkin Lymphoma CD20 Expressing

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    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
    Descrição

    ECOG performance status | WHO performance status scale | Life Expectancy

    Tipo de dados

    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
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

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

    Measurable lesion Single Diameter

    Tipo de dados

    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 )
    Descrição

    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

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    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
    Descrição

    rituximab | Anti-CD20 Antibody

    Tipo de dados

    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
    Descrição

    Hematopoietic Cell Growth Factors | Colony-Stimulating Factors | Erythropoietin

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    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
    Descrição

    Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV

    Tipo de dados

    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 )
    Descrição

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

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    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
    Descrição

    Pregnancy | Breast Feeding | Contraceptive methods Rejected | Gender

    Tipo de dados

    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 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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