ID

41211

Beskrivning

A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01403636

Länk

https://clinicaltrials.gov/show/NCT01403636

Nyckelord

Versioner (1)
  1. 2020-07-14 2020-07-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 juli 2020

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT01403636

Engelsk

Eligibility Lymphoma NCT01403636

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01403636
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
tissue from an archived or fresh tumor sample
Beskrivning

Tumor tissue sample

Datatyp

boolean

Alias
UMLS CUI [1]
C0475358
a peripheral blood buffy coat sample is required for cll/sll.
Beskrivning

Blood smear from peripheral blood Buffy Coat | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4296002
UMLS CUI [1,2]
C2936475
UMLS CUI [2]
C1302547
patient has mantle cell lymphoma (mcl), follicular lymphoma (fl), or chronic lymphocytic leukemia (cll)/sll or diffuse large b cell lymphoma
Beskrivning

Mantle cell lymphoma | Lymphoma, Follicular | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2]
C0024301
UMLS CUI [3]
C1302547
UMLS CUI [4]
C0079744
patient > or = 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status < or = 2. patients with dlbcl will have ecog < or = 1
Beskrivning

ECOG performance status | Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0079744
adequate white blood cells and hemoglobin
Beskrivning

White Blood Cell Count procedure | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
good kidney and liver function
Beskrivning

Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
fasting glucose < 160 mg/dl
Beskrivning

Glucose measurement, fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0202045
no other malignancy
Beskrivning

Cancer Other Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332197
use of adequate birth control
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin c within 6 weeks of study enrollment
Beskrivning

Cytotoxic Chemotherapy | Biological agents | Therapies, Investigational | Nitrosoureas | mitomycin

Datatyp

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0005515
UMLS CUI [3]
C0949266
UMLS CUI [4]
C0028210
UMLS CUI [5]
C0002475
treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
Beskrivning

Small Molecule kinase inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1328819
UMLS CUI [1,2]
C3537035
prior treatment with a pi3k, mtor, or akt inhibitor. prior treatment of mcl with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
Beskrivning

Phosphatidylinositide 3-Kinase Inhibitor | mTOR Inhibitor | AKT1 gene Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2]
C2746052
UMLS CUI [3,1]
C0812228
UMLS CUI [3,2]
C1999216
radiation therapy within 2 weeks of enrollment
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
autologous stem cell transplantation within 16 weeks of enrollment
Beskrivning

Autologous hematopoietic stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C2193200
prior allogeneic transplantation except for patients with r/r dlbcl who meet inclusion criteria
Beskrivning

Transplantation, Homologous

Datatyp

boolean

Alias
UMLS CUI [1]
C0040739
central nervous system (cns) or leptomeningeal involvement. patients with dlbcl may have active cns or leptomeningeal involvement.
Beskrivning

Central Nervous System Involvement | Involvement Leptomeningeal

Datatyp

boolean

Alias
UMLS CUI [1]
C4050309
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0228126
positive hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) serology
Beskrivning

Hepatitis B surface antigen positive | Serology positive Hepatitis C Antibodies

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0166049
primary cns lymphoma
Beskrivning

Primary central nervous system lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0280803
primary mediastinal b-lymphoma
Beskrivning

Mediastinal Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1292754
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status | Considerations Incomplete

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0205257
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Similar models

Eligibility Lymphoma NCT01403636

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01403636
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Tumor tissue sample
Item
tissue from an archived or fresh tumor sample
boolean
C0475358 (UMLS CUI [1])
Blood smear from peripheral blood Buffy Coat | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Item
a peripheral blood buffy coat sample is required for cll/sll.
boolean
C4296002 (UMLS CUI [1,1])
C2936475 (UMLS CUI [1,2])
C1302547 (UMLS CUI [2])
Mantle cell lymphoma | Lymphoma, Follicular | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Diffuse Large B-Cell Lymphoma
Item
patient has mantle cell lymphoma (mcl), follicular lymphoma (fl), or chronic lymphocytic leukemia (cll)/sll or diffuse large b cell lymphoma
boolean
C0334634 (UMLS CUI [1])
C0024301 (UMLS CUI [2])
C1302547 (UMLS CUI [3])
C0079744 (UMLS CUI [4])
Age
Item
patient > or = 18 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Diffuse Large B-Cell Lymphoma
Item
eastern cooperative oncology group (ecog) performance status < or = 2. patients with dlbcl will have ecog < or = 1
boolean
C1520224 (UMLS CUI [1])
C0079744 (UMLS CUI [2])
White Blood Cell Count procedure | Hemoglobin measurement
Item
adequate white blood cells and hemoglobin
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Renal function | Liver function
Item
good kidney and liver function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Glucose measurement, fasting
Item
fasting glucose < 160 mg/dl
boolean
C0202045 (UMLS CUI [1])
Cancer Other Absent
Item
no other malignancy
boolean
C1707251 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Contraceptive methods
Item
use of adequate birth control
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy | Biological agents | Therapies, Investigational | Nitrosoureas | mitomycin
Item
treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin c within 6 weeks of study enrollment
boolean
C0677881 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
Small Molecule kinase inhibitor
Item
treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
boolean
C1328819 (UMLS CUI [1,1])
C3537035 (UMLS CUI [1,2])
Phosphatidylinositide 3-Kinase Inhibitor | mTOR Inhibitor | AKT1 gene Inhibitor
Item
prior treatment with a pi3k, mtor, or akt inhibitor. prior treatment of mcl with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
boolean
C1519050 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C1999216 (UMLS CUI [3,2])
Therapeutic radiology procedure
Item
radiation therapy within 2 weeks of enrollment
boolean
C1522449 (UMLS CUI [1])
Autologous hematopoietic stem cell transplant
Item
autologous stem cell transplantation within 16 weeks of enrollment
boolean
C2193200 (UMLS CUI [1])
Transplantation, Homologous
Item
prior allogeneic transplantation except for patients with r/r dlbcl who meet inclusion criteria
boolean
C0040739 (UMLS CUI [1])
Central Nervous System Involvement | Involvement Leptomeningeal
Item
central nervous system (cns) or leptomeningeal involvement. patients with dlbcl may have active cns or leptomeningeal involvement.
boolean
C4050309 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0228126 (UMLS CUI [2,2])
Hepatitis B surface antigen positive | Serology positive Hepatitis C Antibodies
Item
positive hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) serology
boolean
C0149709 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0166049 (UMLS CUI [2,2])
Primary central nervous system lymphoma
Item
primary cns lymphoma
boolean
C0280803 (UMLS CUI [1])
Mediastinal Large B-Cell Lymphoma
Item
primary mediastinal b-lymphoma
boolean
C1292754 (UMLS CUI [1])
Study Subject Participation Status | Considerations Incomplete
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
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