ID

28057

Description

Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL; ODM derived from: https://clinicaltrials.gov/show/NCT00543114

Lien

https://clinicaltrials.gov/show/NCT00543114

Mots-clés

Versions (1)
  1. 13/12/2017 13/12/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

13 décembre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00543114

Anglais

Eligibility Chronic Lymphocytic Leukemia NCT00543114

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with b-cll/sll based on the standard histologic and immunophenotypic criteria described in the who classification
Description

CLL/SLL WHO classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C1302547
UMLS CUI [1,2]
C4267671
no prior systemic therapy for cll/sll, including chemotherapy or antibody therapy
Description

Systemic therapy Absent CLL/SLL | Chemotherapy Absent | Antibody therapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1302547
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0281176
UMLS CUI [3,2]
C0332197
currently needs therapy based on 1996 nci-wg criteria
Description

Therapeutic procedure Patient need for

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0686904
measurable disease
Description

Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
ecog performance status of 0-2
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
laboratory test results within parameters outlined in protocol
Description

Laboratory test finding Within Study Protocol Parameter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C0332285
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0549193
able to take aspirin daily as prophylactic anticoagulation
Description

Able to take Aspirin Daily | Anticoagulation Prophylactic

Type de données

boolean

Alias
UMLS CUI [1,1]
C4075001
UMLS CUI [1,2]
C0004057
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C0003281
UMLS CUI [2,2]
C0199176
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document
Description

Medical condition Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0021430
pregnant or breast-feeding females
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Description

Laboratory test result abnormal Study Subject Participation Status At risk Unacceptable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1883420
use of any other experimental drug or therapy within 28 days of baseline
Description

Investigational New Drugs | Therapy, Investigational

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
known hypersensitivity to thalidomide
Description

Hypersensitivity Thalidomide

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0039736
development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
Description

Erythema Nodosum | Rash desquamating | Thalidomide | Intake Pharmaceutical Preparations Similar

Type de données

boolean

Alias
UMLS CUI [1]
C0014743
UMLS CUI [2]
C0542171
UMLS CUI [3]
C0039736
UMLS CUI [4,1]
C1512806
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
prior use of lenalidomide
Description

Lenalidomide

Type de données

boolean

Alias
UMLS CUI [1]
C1144149
concurrent use of other anti-cancer agents or treatments
Description

Antineoplastic Agents | Cancer treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0920425
known positive for hiv
Description

HIV Seropositivity

Type de données

boolean

Alias
UMLS CUI [1]
C0019699
chronic active hep b patients not on prophylactic lamivudine
Description

Hepatitis B, Chronic | Lamivudine Prophylactic Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2,1]
C0209738
UMLS CUI [2,2]
C0199176
UMLS CUI [2,3]
C0332197
diagnosis of mantle cell lymphoma
Description

Mantle cell lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C0334634
Retour au début de la page

Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00543114

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
CLL/SLL WHO classification
Item
diagnosed with b-cll/sll based on the standard histologic and immunophenotypic criteria described in the who classification
boolean
C1302547 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
Systemic therapy Absent CLL/SLL | Chemotherapy Absent | Antibody therapy Absent
Item
no prior systemic therapy for cll/sll, including chemotherapy or antibody therapy
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1302547 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0281176 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure Patient need for
Item
currently needs therapy based on 1996 nci-wg criteria
boolean
C0087111 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Laboratory test finding Within Study Protocol Parameter
Item
laboratory test results within parameters outlined in protocol
boolean
C0587081 (UMLS CUI [1,1])
C0332285 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0549193 (UMLS CUI [1,4])
Able to take Aspirin Daily | Anticoagulation Prophylactic
Item
able to take aspirin daily as prophylactic anticoagulation
boolean
C4075001 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0003281 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical condition Preventing Informed Consent | Laboratory test result abnormal Preventing Informed Consent | Mental disorders Preventing Informed Consent
Item
any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Laboratory test result abnormal Study Subject Participation Status At risk Unacceptable
Item
any condition, including the presence of abnormal laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
boolean
C0438215 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
Investigational New Drugs | Therapy, Investigational
Item
use of any other experimental drug or therapy within 28 days of baseline
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Hypersensitivity Thalidomide
Item
known hypersensitivity to thalidomide
boolean
C0020517 (UMLS CUI [1,1])
C0039736 (UMLS CUI [1,2])
Erythema Nodosum | Rash desquamating | Thalidomide | Intake Pharmaceutical Preparations Similar
Item
development of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
boolean
C0014743 (UMLS CUI [1])
C0542171 (UMLS CUI [2])
C0039736 (UMLS CUI [3])
C1512806 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Lenalidomide
Item
prior use of lenalidomide
boolean
C1144149 (UMLS CUI [1])
Antineoplastic Agents | Cancer treatment
Item
concurrent use of other anti-cancer agents or treatments
boolean
C0003392 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
HIV Seropositivity
Item
known positive for hiv
boolean
C0019699 (UMLS CUI [1])
Hepatitis B, Chronic | Lamivudine Prophylactic Absent
Item
chronic active hep b patients not on prophylactic lamivudine
boolean
C0524909 (UMLS CUI [1])
C0209738 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Mantle cell lymphoma
Item
diagnosis of mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Retour au début de la page 

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