ID

29416

Description

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

Link

https://clinicaltrials.gov/show/NCT00850499

Keywords

Versions (1)
  1. 3/22/18 3/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00850499

English

Eligibility Follicular Lymphoma NCT00850499

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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
Description

Follicular Non-Hodgkin's Lymphoma Grade WHO classification

Data type

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
Description

Rituximab Dose Quantity | Therapeutic procedure Containing Rituximab

Data type

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
Description

Recurrent disease Post Antineoplastic Therapy | Disease Progression Post Antineoplastic Therapy

Data type

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)
Description

Tumor Mass Measurable Quantity | Tumor Mass Size

Data type

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
Description

Exclusion Criteria

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

Transformation Aggressive Lymphoma

Data type

boolean

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

Velcade | fludarabine

Data type

boolean

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

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

Data type

boolean

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

Nitrosoureas

Data type

boolean

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

Radioimmunoconjugates | Toxin Immunoconjugates

Data type

boolean

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

Major surgery

Data type

boolean

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

Adrenal Cortex Hormones chronic | Dexamethasone chronic

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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