ID

21828

Description

Safety Study to Evaluate Induction and Consolidation Treatment in Patients With Mantle Cell Lymphoma (LCM-04-02); ODM derived from: https://clinicaltrials.gov/show/NCT00505232

Link

https://clinicaltrials.gov/show/NCT00505232

Keywords

Versions (1)
  1. 5/3/17 5/3/17 -
Uploaded on

May 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Mantle Cell Lymphoma NCT00505232

English

Eligibility Mantle Cell Lymphoma NCT00505232

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all histologic mcl subtypes (who classification)
Description

Mantle cell lymphoma Subtypes WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0334634
UMLS CUI [1,2]
C0872379
UMLS CUI [1,3]
C1301142
age between 18 and 70 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status 0 to 2 (ecog)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
cardiac ejection fraction >50%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
adequate organ (hepatic, cardiac and renal) and marrow function: hb> 10g/dl, neutrophil counts> 1500/ µl, platelet> 100000/ µl. creatinine < 2,5xuln, bilirubin, ast or alt<2,5xuln.
Description

Liver function | Cardiac function | Renal function | Bone Marrow function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232164
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0200633
UMLS CUI [7]
C0032181
UMLS CUI [8]
C0201976
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0201899
UMLS CUI [11]
C0201836
for y90-ibritumomab tiuxetan administration: bone marrow infiltration by lymphoma cells < than 25% ; platelet count >100,000/µl and neutrophil counts >1500/µl
Description

yttrium-90-ibritumomab tiuxetan Administration | Bone marrow infiltration Percentage Lymphoma cells | Platelet Count measurement | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1,1]
C1134535
UMLS CUI [1,2]
C1533734
UMLS CUI [2,1]
C3854434
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0883208
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0200633
informed consent should be obtained
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ann arbor stages i or ii without b symptoms or bulky disease (>10 cm).
Description

Ann Arbor lymphoma staging system | B-Symptoms Absent | Bulky Disease Tumor size

Data type

boolean

Alias
UMLS CUI [1]
C0432516
UMLS CUI [2,1]
C1706867
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1511341
UMLS CUI [3,2]
C0475440
previous chemotherapy or radiotherapy treatment.
Description

Chemotherapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
uncontrolled current illness: hepatic, renal, cardiovascular, neurological or metabolic illness.
Description

Illness Uncontrolled | Liver diseases | Kidney Diseases | Cardiovascular Diseases | nervous system disorder | Metabolic Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0025517
symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
Description

Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0742758
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0003811
hiv, hbv or hcv positive serology.
Description

HIV Seropositivity | Hepatitis B Virus Seropositive | Hepatitis C virus Seropositive

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0019169
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0220847
UMLS CUI [3,2]
C0521143
limitation of the patient´s ability to comply with the treatment or follow-up protocol.
Description

Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0439801
men and women with reproductive potential who are not using effective contraceptive methods during and at least 12 months after the end of the study
Description

Females & males of reproductive potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
acute or chronic active infection.
Description

Communicable Disease | Chronic infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
known hypersensitivity to some of the drugs or other related compounds
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Compound Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0439849
no informed consent obtained
Description

Informed Consent Missing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705492
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Similar models

Eligibility Mantle Cell Lymphoma NCT00505232

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma Subtypes WHO tumor classification
Item
all histologic mcl subtypes (who classification)
boolean
C0334634 (UMLS CUI [1,1])
C0872379 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])
Age
Item
age between 18 and 70 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
performance status 0 to 2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Cardiac ejection fraction
Item
cardiac ejection fraction >50%
boolean
C0232174 (UMLS CUI [1])
Liver function | Cardiac function | Renal function | Bone Marrow function | Hemoglobin measurement | Neutrophil count | Platelet Count measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate organ (hepatic, cardiac and renal) and marrow function: hb> 10g/dl, neutrophil counts> 1500/ µl, platelet> 100000/ µl. creatinine < 2,5xuln, bilirubin, ast or alt<2,5xuln.
boolean
C0232741 (UMLS CUI [1])
C0232164 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0518015 (UMLS CUI [5])
C0200633 (UMLS CUI [6])
C0032181 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0201836 (UMLS CUI [11])
yttrium-90-ibritumomab tiuxetan Administration | Bone marrow infiltration Percentage Lymphoma cells | Platelet Count measurement | Neutrophil count
Item
for y90-ibritumomab tiuxetan administration: bone marrow infiltration by lymphoma cells < than 25% ; platelet count >100,000/µl and neutrophil counts >1500/µl
boolean
C1134535 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C3854434 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0883208 (UMLS CUI [2,3])
C0032181 (UMLS CUI [3])
C0200633 (UMLS CUI [4])
Informed Consent
Item
informed consent should be obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Ann Arbor lymphoma staging system | B-Symptoms Absent | Bulky Disease Tumor size
Item
ann arbor stages i or ii without b symptoms or bulky disease (>10 cm).
boolean
C0432516 (UMLS CUI [1])
C1706867 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1511341 (UMLS CUI [3,1])
C0475440 (UMLS CUI [3,2])
Chemotherapy | Therapeutic radiology procedure
Item
previous chemotherapy or radiotherapy treatment.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Illness Uncontrolled | Liver diseases | Kidney Diseases | Cardiovascular Diseases | nervous system disorder | Metabolic Diseases
Item
uncontrolled current illness: hepatic, renal, cardiovascular, neurological or metabolic illness.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia
Item
symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
boolean
C0742758 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B Virus Seropositive | Hepatitis C virus Seropositive
Item
hiv, hbv or hcv positive serology.
boolean
C0019699 (UMLS CUI [1])
C0019169 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0220847 (UMLS CUI [3,1])
C0521143 (UMLS CUI [3,2])
Protocol Compliance Limited
Item
limitation of the patient´s ability to comply with the treatment or follow-up protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Females & males of reproductive potential Contraceptive methods Lacking
Item
men and women with reproductive potential who are not using effective contraceptive methods during and at least 12 months after the end of the study
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Communicable Disease | Chronic infection
Item
acute or chronic active infection.
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Compound Related
Item
known hypersensitivity to some of the drugs or other related compounds
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
Informed Consent Missing
Item
no informed consent obtained
boolean
C0021430 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
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