ID

34887

Descripción

A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02456207

Link

https://clinicaltrials.gov/show/NCT02456207

Palabras clave

Versiones (1)
  1. 2/2/19 2/2/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de febrero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility B-cell Non Hodgkin's Lymphoma NCT02456207

Inglés

Eligibility B-cell Non Hodgkin's Lymphoma NCT02456207

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged from 18 to 75 years;
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. having histologically confirmed nhl expressing cd20 antigen;
Descripción

Non-Hodgkin Lymphoma CD20 expressing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C3888518
3. having obtained cr (complete remission) or cru (uncertain complete remisson) after the prior therapy;
Descripción

In complete remission Post Prior Therapy | Complete remission Uncertain Post Prior Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0087130
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C1514463
4. ecog performance status of 0 to 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
5. expected survival of at least ≥ 3 months;
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
6. signed an informed consent form which was approved by the institutional review board of the respective medical center .
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 year before enrollment;
Descripción

rituximab | Anti-CD20 Antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C3891557
2. having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy;
Descripción

Cancer treatment Previous | Adrenal Cortex Hormones Previous | Prior Therapy Toxicity Recovery Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0600688
UMLS CUI [3,3]
C2004454
UMLS CUI [3,4]
C0332268
3. participating in other clinical trial within 30 days before enrolment;
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
4. with serious hematologic dysfunction (white blood cell count of <3.0×103/ul; absolute neutrophil count of <1.5×103/ ul; platelet count of < 75×103/ul; hemoglobin level of < 8.0 g/dl); hepatic dysfunction (total bilirubin level of > 1.5×uln; aspartate amino transferase (ast) and alanine amino transferase (alt) levels of >2.5 × uln; renal dysfunction (serum creatinine level of > 1.5×uln ); and international normalized ratio (inr) and partial thromboplastin time or activated partial thromboplastin time (aptt) > 1.5 × uln (unless on therapeutic coagulation);
Descripción

Hematologic function Impaired | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Renal dysfunction | Serum creatinine raised | INR raised | Partial thromboplastin time increased | Prolonged activated partial thromboplastin time (aPTT) | Exception Coagulation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0086565
UMLS CUI [7]
C0741494
UMLS CUI [8]
C0151904
UMLS CUI [9]
C0151905
UMLS CUI [10]
C3279454
UMLS CUI [11]
C0700225
UMLS CUI [12]
C0853225
UMLS CUI [13]
C0240671
UMLS CUI [14]
C1837411
UMLS CUI [15,1]
C1705847
UMLS CUI [15,2]
C0441509
5. had received live vaccine within 4 weeks prior to study entry;
Descripción

Vaccines, Attenuated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042211
6. with other malignancies ; or central nervous system (cns) lymphoma, aids-related lymphoma; or active opportunistic infection, a serious nonmalignant disease;
Descripción

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

Tipo de datos

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]
C0205404
UMLS CUI [5,3]
C0332300
UMLS CUI [5,4]
C0006826
7. seropositive for hcv antibody, or hiv antibody, or hepatitis b virus surface antigen (hbsag). hbc antibody seropositive, but hbv dna and hbsag negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of hbv antiviral therapy, and provided they agree to receive treatment as indicated,
Descripción

Hepatitis C Antibody Seropositive | HIV Antibody Seropositive | Hepatitis B Surface Antigens Seropositive | Anti-HBc antibody Seropositive | Hbv DNA Test Negative allowed | Hepatitis B surface antigen negative allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0019683
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C0521143
UMLS CUI [4,1]
C0948759
UMLS CUI [4,2]
C0521143
UMLS CUI [5,1]
C1256114
UMLS CUI [5,2]
C1513916
UMLS CUI [5,3]
C0683607
UMLS CUI [6,1]
C0919711
UMLS CUI [6,2]
C0683607
8. recent major surgery (within 28 days prior to study entry );
Descripción

Major surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0679637
9. with a history of allergic reaction or protein product allergy including murine proteins;
Descripción

Allergic Reaction Proteins | Protein allergy | Hypersensitivity Murine protein

Tipo de datos

boolean

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

Pregnancy | Breast Feeding | Gender Contraceptive methods Rejected

Tipo de datos

boolean

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

Eligibility B-cell Non Hodgkin's Lymphoma NCT02456207

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. aged from 18 to 75 years;
boolean
C0001779 (UMLS CUI [1])
Non-Hodgkin Lymphoma CD20 expressing
Item
2. having histologically confirmed nhl expressing cd20 antigen;
boolean
C0024305 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
In complete remission Post Prior Therapy | Complete remission Uncertain Post Prior Therapy
Item
3. having obtained cr (complete remission) or cru (uncertain complete remisson) after the prior therapy;
boolean
C0677874 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2,1])
C0087130 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C1514463 (UMLS CUI [2,4])
ECOG performance status
Item
4. ecog performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. expected survival of at least ≥ 3 months;
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
6. 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)
rituximab | Anti-CD20 Antibody
Item
1. had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 year before enrollment;
boolean
C0393022 (UMLS CUI [1])
C3891557 (UMLS CUI [2])
Cancer treatment Previous | Adrenal Cortex Hormones Previous | Prior Therapy Toxicity Recovery Lacking
Item
2. having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy;
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
Study Subject Participation Status
Item
3. participating in other clinical trial within 30 days before enrolment;
boolean
C2348568 (UMLS CUI [1])
Hematologic function Impaired | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Renal dysfunction | Serum creatinine raised | INR raised | Partial thromboplastin time increased | Prolonged activated partial thromboplastin time (aPTT) | Exception Coagulation therapy
Item
4. with serious hematologic dysfunction (white blood cell count of <3.0×103/ul; absolute neutrophil count of <1.5×103/ ul; platelet count of < 75×103/ul; hemoglobin level of < 8.0 g/dl); hepatic dysfunction (total bilirubin level of > 1.5×uln; aspartate amino transferase (ast) and alanine amino transferase (alt) levels of >2.5 × uln; renal dysfunction (serum creatinine level of > 1.5×uln ); and international normalized ratio (inr) and partial thromboplastin time or activated partial thromboplastin time (aptt) > 1.5 × uln (unless on therapeutic coagulation);
boolean
C0221130 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0086565 (UMLS CUI [6])
C0741494 (UMLS CUI [7])
C0151904 (UMLS CUI [8])
C0151905 (UMLS CUI [9])
C3279454 (UMLS CUI [10])
C0700225 (UMLS CUI [11])
C0853225 (UMLS CUI [12])
C0240671 (UMLS CUI [13])
C1837411 (UMLS CUI [14])
C1705847 (UMLS CUI [15,1])
C0441509 (UMLS CUI [15,2])
Vaccines, Attenuated
Item
5. had received live vaccine within 4 weeks prior to study entry;
boolean
C0042211 (UMLS CUI [1])
Cancer Other | Central nervous system lymphoma | Lymphoma, AIDS-Related | Opportunistic Infection | Disease Serious Except Malignant Neoplasms
Item
6. 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])
C0205404 (UMLS CUI [5,2])
C0332300 (UMLS CUI [5,3])
C0006826 (UMLS CUI [5,4])
Hepatitis C Antibody Seropositive | HIV Antibody Seropositive | Hepatitis B Surface Antigens Seropositive | Anti-HBc antibody Seropositive | Hbv DNA Test Negative allowed | Hepatitis B surface antigen negative allowed
Item
7. seropositive for hcv antibody, or hiv antibody, or hepatitis b virus surface antigen (hbsag). hbc antibody seropositive, but hbv dna and hbsag negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of hbv antiviral therapy, and provided they agree to receive treatment as indicated,
boolean
C0166049 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
C0948759 (UMLS CUI [4,1])
C0521143 (UMLS CUI [4,2])
C1256114 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
C0919711 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Major surgery
Item
8. recent major surgery (within 28 days prior to study entry );
boolean
C0679637 (UMLS CUI [1])
Allergic Reaction Proteins | Protein allergy | Hypersensitivity Murine protein
Item
9. 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])
C0020517 (UMLS CUI [3,1])
C1699668 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Rejected
Item
10. pregnant or lactating or not accepted birth control methods including male patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1548437 (UMLS CUI [3,3])
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