ID

35324

Beschreibung

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01980888

Link

https://clinicaltrials.gov/show/NCT01980888

Stichworte

Versionen (1)
  1. 28.02.19 28.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Februar 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT01980888

Englisch

Eligibility Chronic Lymphocytic Leukemia NCT01980888

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll)
Beschreibung

Chronic Lymphocytic Leukemia

Datentyp

boolean

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

Prior Therapy Absent Chronic Lymphocytic Leukemia | Exception Adrenal Cortex Hormones Disease complication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0023434
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C0544688
cll that warrants treatment
Beschreibung

Chronic Lymphocytic Leukemia Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0332121
presence of measurable lymphadenopathy
Beschreibung

Lymphadenopathy Measurable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1513040
eastern cooperative oncology group (ecog) performance status of ≤ 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known histological transformation from cll to an aggressive lymphoma (ie, richter transformation)
Beschreibung

Chronic lymphocytic leukaemia transformation Aggressive lymphoma | Richter's syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1142081
UMLS CUI [1,2]
C1332225
UMLS CUI [2]
C0349631
known presence of myelodysplastic syndrome
Beschreibung

MYELODYSPLASTIC SYNDROME

Datentyp

boolean

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

Systemic bacterial infection | Systemic mycosis | Systemic viral infection

Datentyp

boolean

Alias
UMLS CUI [1]
C4285778
UMLS CUI [2]
C0553576
UMLS CUI [3]
C4285789
ongoing liver injury
Beschreibung

Injury of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0160390
history of non-infectious pneumonitis
Beschreibung

Non-infectious pneumonia

Datentyp

boolean

Alias
UMLS CUI [1]
C0264376
ongoing inflammatory bowel disease
Beschreibung

Inflammatory Bowel Disease

Datentyp

boolean

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

Bone Marrow Stem Cell Transplantation Allogeneic | Solid organ transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0842093
UMLS CUI [1,2]
C1515895
UMLS CUI [2]
C0730400
ongoing immunosuppressive therapy other than corticosteroids
Beschreibung

Therapeutic immunosuppression | Exception Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Chronic Lymphocytic Leukemia NCT01980888

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia
Item
documented diagnosis of b-cell cll, with diagnosis established according to international workshop on chronic lymphocytic leukemia (iwcll)
boolean
C0023434 (UMLS CUI [1])
Prior Therapy Absent Chronic Lymphocytic Leukemia | Exception Adrenal Cortex Hormones Disease complication
Item
no prior therapy for cll other than corticosteroids for disease complications
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C0544688 (UMLS CUI [2,3])
Chronic Lymphocytic Leukemia Treatment required for
Item
cll that warrants treatment
boolean
C0023434 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Lymphadenopathy Measurable
Item
presence of measurable lymphadenopathy
boolean
C0497156 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic lymphocytic leukaemia transformation Aggressive lymphoma | Richter's syndrome
Item
known histological transformation from cll to an aggressive lymphoma (ie, richter transformation)
boolean
C1142081 (UMLS CUI [1,1])
C1332225 (UMLS CUI [1,2])
C0349631 (UMLS CUI [2])
MYELODYSPLASTIC SYNDROME
Item
known presence of myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
Systemic bacterial infection | Systemic mycosis | Systemic viral infection
Item
evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
boolean
C4285778 (UMLS CUI [1])
C0553576 (UMLS CUI [2])
C4285789 (UMLS CUI [3])
Injury of liver
Item
ongoing liver injury
boolean
C0160390 (UMLS CUI [1])
Non-infectious pneumonia
Item
history of non-infectious pneumonitis
boolean
C0264376 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
ongoing inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Bone Marrow Stem Cell Transplantation Allogeneic | Solid organ transplant
Item
history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
boolean
C0842093 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
C0730400 (UMLS CUI [2])
Therapeutic immunosuppression | Exception Adrenal Cortex Hormones
Item
ongoing immunosuppressive therapy other than corticosteroids
boolean
C0021079 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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