ID

29416

Descrizione

Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab; ODM derived from: https://clinicaltrials.gov/show/NCT00850499

collegamento

https://clinicaltrials.gov/show/NCT00850499

Keywords

versioni (1)
  1. 22/03/18 22/03/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

22 marzo 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00850499

Inglese

Eligibility Follicular Lymphoma NCT00850499

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects 18 years or older
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven diagnosis of follicular non-hodgkin's lymphoma grades 1or 2 according to the world health organization classification
Descrizione

Follicular Non-Hodgkin's Lymphoma Grade WHO classification

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C4267671
subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
Descrizione

Rituximab Dose Quantity | Therapeutic procedure Containing Rituximab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0393022
documented relapse or progression following last antineoplastic treatment
Descrizione

Recurrent disease Post Antineoplastic Therapy | Disease Progression Post Antineoplastic Therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2346834
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2346834
at least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
Descrizione

Tumor Mass Measurable Quantity | Tumor Mass Size

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C0456389
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with histological or clinical transformation to an aggressive lymphoma
Descrizione

Transformation Aggressive Lymphoma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3714584
UMLS CUI [1,2]
C1332225
prior treatment with velcade or fludarabine.
Descrizione

Velcade | fludarabine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1174739
UMLS CUI [2]
C0059985
antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
Descrizione

Antineoplastic Therapy | Monoclonal antibody unconjugated therapy | Therapy, Investigational | Therapeutic radiology procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0854644
UMLS CUI [3]
C0949266
UMLS CUI [4]
C1522449
nitrosoureas within 6 weeks before randomization
Descrizione

Nitrosoureas

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0028210
radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
Descrizione

Radioimmunoconjugates | Toxin Immunoconjugates

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0243019
UMLS CUI [2,1]
C0040549
UMLS CUI [2,2]
C0243020
major surgery within 3 weeks before randomization
Descrizione

Major surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0679637
chronic use of corticosteroids, such as dexamethasone
Descrizione

Adrenal Cortex Hormones chronic | Dexamethasone chronic

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0011777
UMLS CUI [2,2]
C0205191
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Similar models

Eligibility Follicular Lymphoma NCT00850499

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects 18 years or older
boolean
C0001779 (UMLS CUI [1])
Follicular Non-Hodgkin's Lymphoma Grade WHO classification
Item
histologically proven diagnosis of follicular non-hodgkin's lymphoma grades 1or 2 according to the world health organization classification
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C4267671 (UMLS CUI [1,3])
Rituximab Dose Quantity | Therapeutic procedure Containing Rituximab
Item
subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
boolean
C0393022 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0393022 (UMLS CUI [2,3])
Recurrent disease Post Antineoplastic Therapy | Disease Progression Post Antineoplastic Therapy
Item
documented relapse or progression following last antineoplastic treatment
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2346834 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2346834 (UMLS CUI [2,3])
Tumor Mass Measurable Quantity | Tumor Mass Size
Item
at least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
boolean
C3273930 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3273930 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Transformation Aggressive Lymphoma
Item
subjects with histological or clinical transformation to an aggressive lymphoma
boolean
C3714584 (UMLS CUI [1,1])
C1332225 (UMLS CUI [1,2])
Velcade | fludarabine
Item
prior treatment with velcade or fludarabine.
boolean
C1174739 (UMLS CUI [1])
C0059985 (UMLS CUI [2])
Antineoplastic Therapy | Monoclonal antibody unconjugated therapy | Therapy, Investigational | Therapeutic radiology procedure
Item
antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
boolean
C2346834 (UMLS CUI [1])
C0854644 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Nitrosoureas
Item
nitrosoureas within 6 weeks before randomization
boolean
C0028210 (UMLS CUI [1])
Radioimmunoconjugates | Toxin Immunoconjugates
Item
radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
boolean
C0243019 (UMLS CUI [1])
C0040549 (UMLS CUI [2,1])
C0243020 (UMLS CUI [2,2])
Major surgery
Item
major surgery within 3 weeks before randomization
boolean
C0679637 (UMLS CUI [1])
Adrenal Cortex Hormones chronic | Dexamethasone chronic
Item
chronic use of corticosteroids, such as dexamethasone
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0011777 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
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