ID

11984

Description

Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01980875

Link

https://clinicaltrials.gov/show/NCT01980875

Keywords

Versions (1)
  1. 8/30/15 8/30/15 -
Copyright Holder

https://clinicaltrials.gov/show/NCT01980875

Uploaded on

August 30, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT01980875

English

Eligibility Chronic Lymphocytic Leukemia NCT01980875

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

not a candidate for fludarabine therapy based on either:
Description

therapy

Data type

boolean

Alias
UMLS CUI [1]
C0087111
1. creatinine clearance < 70 ml/min, or
Description

creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0373595
2. cumulative illness rating scale score > 6, by assessment of the investigator
Description

investigator; assessment; score

Data type

boolean

Alias
UMLS CUI [1]
C0582608
diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll)
Description

diagnosis; leukemia; chronic; cll

Data type

boolean

Alias
UMLS CUI [1]
C0023434
no prior therapy for cll other than corticosteroids for disease complications.
Description

corticosteroids; complications; prior therapy; other; disease; cll

Data type

boolean

Alias
UMLS CUI [1]
C0023434
cll that warrants treatment
Description

treatment; cll

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C0023434
presence of measurable lymphadenopathy
Description

measurable

Data type

boolean

Alias
UMLS CUI [1]
C0497156
eastern cooperative oncology group (ecog) performance status of ≤ 2
Description

eastern cooperative oncology group (ecog) performance status < 1; eastern cooperative oncology group (ecog) performance status 0-2

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

known histological transformation from cll to an aggressive lymphoma (ie, richter transformation)
Description

lymphoma; from; cll

Data type

boolean

Alias
UMLS CUI [1]
C0349631
known presence of myelodysplastic syndrome
Description

myelodysplastic syndrome

Data type

boolean

Alias
UMLS CUI [1]
C3463824
evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
Description

randomization; evidence of; infection; systemic; ongoing; viral; time

Data type

boolean

Alias
UMLS CUI [1]
C0243026
ongoing liver injury
Description

ongoing; liver

Data type

boolean

Alias
UMLS CUI [1]
C0160390
ongoing drug-induced pneumonitis
Description

pneumonitis; ongoing; drug

Data type

boolean

Alias
UMLS CUI [1]
C3714636
ongoing inflammatory bowel disease
Description

inflammatory; disease; ongoing

Data type

boolean

Alias
UMLS CUI [1]
C0021390
history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Description

organ transplantation; bone marrow; solid organ

Data type

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0149615
ongoing immunosuppressive therapy other than corticosteroids
Description

corticosteroids; other; ongoing; therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
concurrent participation in another therapeutic clinical trial
Description

clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C0008976
undergone major surgery within 30 days prior to randomization
Description

major surgery; randomization

Data type

boolean

Alias
UMLS CUI [1]
C0679637
known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idela, obinutuzumab, or chlorambucil
Description

hypersensitivity; active substance

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1254351
history of non-infectious pneumonitis
Description

pneumonitis; non

Data type

boolean

Alias
UMLS CUI [1]
C0264376
received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
Description

clinical trial; randomization; study; dose; last; drug

Data type

boolean

Alias
UMLS CUI [1]
C0013175
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT01980875

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
therapy
Item
not a candidate for fludarabine therapy based on either:
boolean
C0087111 (UMLS CUI [1])
creatinine clearance
Item
1. creatinine clearance < 70 ml/min, or
boolean
C0373595 (UMLS CUI [1])
investigator; assessment; score
Item
2. cumulative illness rating scale score > 6, by assessment of the investigator
boolean
C0582608 (UMLS CUI [1])
diagnosis; leukemia; chronic; cll
Item
diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll)
boolean
C0023434 (UMLS CUI [1])
corticosteroids; complications; prior therapy; other; disease; cll
Item
no prior therapy for cll other than corticosteroids for disease complications.
boolean
C0023434 (UMLS CUI [1])
treatment; cll
Item
cll that warrants treatment
boolean
C0087111 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
measurable
Item
presence of measurable lymphadenopathy
boolean
C0497156 (UMLS CUI [1])
eastern cooperative oncology group (ecog) performance status < 1; eastern cooperative oncology group (ecog) performance status 0-2
Item
eastern cooperative oncology group (ecog) performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
lymphoma; from; cll
Item
known histological transformation from cll to an aggressive lymphoma (ie, richter transformation)
boolean
C0349631 (UMLS CUI [1])
myelodysplastic syndrome
Item
known presence of myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
randomization; evidence of; infection; systemic; ongoing; viral; time
Item
evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
boolean
C0243026 (UMLS CUI [1])
ongoing; liver
Item
ongoing liver injury
boolean
C0160390 (UMLS CUI [1])
pneumonitis; ongoing; drug
Item
ongoing drug-induced pneumonitis
boolean
C3714636 (UMLS CUI [1])
inflammatory; disease; ongoing
Item
ongoing inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
organ transplantation; bone marrow; solid organ
Item
history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
boolean
C0029216 (UMLS CUI [1])
C0149615 (UMLS CUI [2])
corticosteroids; other; ongoing; therapy
Item
ongoing immunosuppressive therapy other than corticosteroids
boolean
C0021079 (UMLS CUI [1])
clinical trial
Item
concurrent participation in another therapeutic clinical trial
boolean
C0008976 (UMLS CUI [1])
major surgery; randomization
Item
undergone major surgery within 30 days prior to randomization
boolean
C0679637 (UMLS CUI [1])
hypersensitivity; active substance
Item
known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idela, obinutuzumab, or chlorambucil
boolean
C0020517 (UMLS CUI [1,1])
C1254351 (UMLS CUI [1,2])
pneumonitis; non
Item
history of non-infectious pneumonitis
boolean
C0264376 (UMLS CUI [1])
clinical trial; randomization; study; dose; last; drug
Item
received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
boolean
C0013175 (UMLS CUI [1])
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