ID

41200

Description

A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe); ODM derived from: https://clinicaltrials.gov/show/NCT01056510

Link

https://clinicaltrials.gov/show/NCT01056510

Keywords

  1. 7/11/20 7/11/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 11, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Lymphocytic Leukemia, Chronic NCT01056510

Eligibility Lymphocytic Leukemia, Chronic NCT01056510

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/=18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
chronic lymphocytic leukemia
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
active cll with progressive binet stage b or c
Description

Chronic Lymphocytic Leukemia Binet Staging System

Data type

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C1511118
ineligible for treatment with fludarabine
Description

Patient Ineligible Fludarabine

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0059985
for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
Description

Second line treatment | Pretreatment Rituximab | Pretreatment Chlorambucil

Data type

boolean

Alias
UMLS CUI [1]
C1710038
UMLS CUI [2,1]
C3539076
UMLS CUI [2,2]
C0393022
UMLS CUI [3,1]
C3539076
UMLS CUI [3,2]
C0008163
eocg performance status >/=2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have relapsed within <12 months of first dose of prior rituximab or chlorambucil first-line therapy
Description

Recurrent disease | Status post Rituximab | Status post Chlorambucil First line treatment

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0393022
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0008163
UMLS CUI [3,3]
C1708063
previous or planned stem cell transplantation
Description

Stem cell transplant Previous | Stem cell transplant Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1504389
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1504389
UMLS CUI [2,2]
C1301732
radioimmunotherapy within 6 months prior to starting study treatment
Description

Radioimmunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0085101
transformation to aggressive b-cell malignancy
Description

Transformation Aggressive malignancy B-cell

Data type

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C3149729
UMLS CUI [1,3]
C0004561
any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone or equivalent
Description

Cancer treatment Other | Glucocorticoids | Prednisolone U/day | Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0017710
UMLS CUI [3,1]
C0032950
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0205163

Similar models

Eligibility Lymphocytic Leukemia, Chronic NCT01056510

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Chronic Lymphocytic Leukemia
Item
chronic lymphocytic leukemia
boolean
C0023434 (UMLS CUI [1])
Chronic Lymphocytic Leukemia Binet Staging System
Item
active cll with progressive binet stage b or c
boolean
C0023434 (UMLS CUI [1,1])
C1511118 (UMLS CUI [1,2])
Patient Ineligible Fludarabine
Item
ineligible for treatment with fludarabine
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0059985 (UMLS CUI [1,3])
Second line treatment | Pretreatment Rituximab | Pretreatment Chlorambucil
Item
for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed
boolean
C1710038 (UMLS CUI [1])
C3539076 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
C3539076 (UMLS CUI [3,1])
C0008163 (UMLS CUI [3,2])
ECOG performance status
Item
eocg performance status >/=2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Recurrent disease | Status post Rituximab | Status post Chlorambucil First line treatment
Item
patients who have relapsed within <12 months of first dose of prior rituximab or chlorambucil first-line therapy
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0008163 (UMLS CUI [3,2])
C1708063 (UMLS CUI [3,3])
Stem cell transplant Previous | Stem cell transplant Planned
Item
previous or planned stem cell transplantation
boolean
C1504389 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Radioimmunotherapy
Item
radioimmunotherapy within 6 months prior to starting study treatment
boolean
C0085101 (UMLS CUI [1])
Transformation Aggressive malignancy B-cell
Item
transformation to aggressive b-cell malignancy
boolean
C0040682 (UMLS CUI [1,1])
C3149729 (UMLS CUI [1,2])
C0004561 (UMLS CUI [1,3])
Cancer treatment Other | Glucocorticoids | Prednisolone U/day | Equivalent
Item
any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone or equivalent
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2])
C0032950 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0205163 (UMLS CUI [4])

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