ID

41211

Description

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

Lien

https://clinicaltrials.gov/show/NCT01403636

Mots-clés

Versions (1)
  1. 14/07/2020 14/07/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

14 juillet 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01403636

Anglais

Eligibility Lymphoma NCT01403636

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01403636
Inclusion Criteria
Description

Inclusion Criteria

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

Tumor tissue sample

Type de données

boolean

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

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

Type de données

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
Description

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

Type de données

boolean

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

Age

Type de données

boolean

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

ECOG performance status | Diffuse Large B-Cell Lymphoma

Type de données

boolean

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

White Blood Cell Count procedure | Hemoglobin measurement

Type de données

boolean

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

Renal function | Liver function

Type de données

boolean

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

Glucose measurement, fasting

Type de données

boolean

Alias
UMLS CUI [1]
C0202045
no other malignancy
Description

Cancer Other Absent

Type de données

boolean

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

Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

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
Description

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

Type de données

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
Description

Small Molecule kinase inhibitor

Type de données

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.
Description

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

Type de données

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
Description

Therapeutic radiology procedure

Type de données

boolean

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

Autologous hematopoietic stem cell transplant

Type de données

boolean

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

Transplantation, Homologous

Type de données

boolean

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

Central Nervous System Involvement | Involvement Leptomeningeal

Type de données

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
Description

Hepatitis B surface antigen positive | Serology positive Hepatitis C Antibodies

Type de données

boolean

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

Primary central nervous system lymphoma

Type de données

boolean

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

Mediastinal Large B-Cell Lymphoma

Type de données

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.
Description

Study Subject Participation Status | Considerations Incomplete

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0205257
Retour au début de la page

Similar models

Eligibility Lymphoma NCT01403636

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01403636
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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