ID

40395

Beskrivning

Bendamustine Hydrochloride (HCl) in Indolent Non-Hodgkin's Lymphoma That Has Progressed During or Following Treatment With a Rituximab Regimen or Previously Untreated Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01500083

Länk

https://clinicaltrials.gov/show/NCT01500083

Nyckelord

Versioner (1)
  1. 2020-04-18 2020-04-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 april 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Indolent Non-Hodgkin's Lymphoma NCT01500083

Engelsk

Eligibility Indolent Non-Hodgkin's Lymphoma NCT01500083

1 Formulär  
Criteria
Beskrivning

Criteria

the patient has biopsy-confirmed diagnosis of indolent b-cell nhl documented as relapsed or refractory inhl (following rituximab-based therapy).
Beskrivning

B-cell Indolent Non-Hodgkin Lymphoma Relapsed | B-cell Indolent Non-Hodgkin Lymphoma refractory | Status post Rituximab therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C0004561
UMLS CUI [1,3]
C0205336
UMLS CUI [2,1]
C1334170
UMLS CUI [2,2]
C0004561
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C4047978
the patient has one of the following types of indolent b-cell lymphoma:
Beskrivning

B-Cell Lymphoma indolent | Type Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C0234227
UMLS CUI [2,1]
C0332307
UMLS CUI [2,2]
C1265611
follicular lymphoma grade 1, 2, or 3a
Beskrivning

Follicular Lymphoma Grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
marginal zone lymphoma
Beskrivning

Marginal zone lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0242647
lymphoplasmacytic lymphoma
Beskrivning

Waldenstrom Macroglobulinemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0024419
small lymphocytic lymphoma
Beskrivning

Small Lymphocytic Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0855095
the patient has adequate haematologic function (unless abnormalities are related to lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma).
Beskrivning

Hematologic function | Exception Bone Marrow Involvement Lymphoma | Exception Hypersplenism caused by Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1517677
UMLS CUI [2,3]
C0024299
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020532
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0024299
inclusion criteria for cll:
Beskrivning

Inclusion criteria Chronic Lymphocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0023434
the patient has previously confirmed (according to who criteria) untreated symptomatic chronic b-cell lymphocytic leukemia binet stage b or binet stage c or rai stage ii to iv in need of medical treatment.
Beskrivning

Chronic Lymphocytic Leukemia Symptomatic Untreated | Binet Staging System | Rai Staging System | Patient need for Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332155
UMLS CUI [2]
C1511118
UMLS CUI [3]
C1514715
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0087111
the patient has an eastern cooperative oncology group (ecog) performance status of 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has participated in a clinical study <30 days prior to the screening visit.
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
the patient has one or more of the following conditions:
Beskrivning

Patient Condition Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C1265611
active transformed lymphoma
Beskrivning

Lymphoma transformation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0040682
any history of central nervous system or leptomeningeal lymphoma
Beskrivning

Central nervous system lymphoma | Meningeal Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0280803
UMLS CUI [2]
C2213017
an active malignancy other than the target cancer within the past 5 years
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
human immunodeficiency virus
Beskrivning

HIV

Datatyp

boolean

Alias
UMLS CUI [1]
C0019682
the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Beskrivning

Protocol Compliance Unlikely | Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
other inclusion and exclusion criteria may apply.
Beskrivning

Eligibility Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
Tillbaka till toppen

Similar models

Eligibility Indolent Non-Hodgkin's Lymphoma NCT01500083

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
B-cell Indolent Non-Hodgkin Lymphoma Relapsed | B-cell Indolent Non-Hodgkin Lymphoma refractory | Status post Rituximab therapy
Item
the patient has biopsy-confirmed diagnosis of indolent b-cell nhl documented as relapsed or refractory inhl (following rituximab-based therapy).
boolean
C1334170 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C0205336 (UMLS CUI [1,3])
C1334170 (UMLS CUI [2,1])
C0004561 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C4047978 (UMLS CUI [3,2])
B-Cell Lymphoma indolent | Type Quantity
Item
the patient has one of the following types of indolent b-cell lymphoma:
boolean
C0079731 (UMLS CUI [1,1])
C0234227 (UMLS CUI [1,2])
C0332307 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Follicular Lymphoma Grade
Item
follicular lymphoma grade 1, 2, or 3a
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Marginal zone lymphoma
Item
marginal zone lymphoma
boolean
C0242647 (UMLS CUI [1])
Waldenstrom Macroglobulinemia
Item
lymphoplasmacytic lymphoma
boolean
C0024419 (UMLS CUI [1])
Small Lymphocytic Lymphoma
Item
small lymphocytic lymphoma
boolean
C0855095 (UMLS CUI [1])
Hematologic function | Exception Bone Marrow Involvement Lymphoma | Exception Hypersplenism caused by Lymphoma
Item
the patient has adequate haematologic function (unless abnormalities are related to lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma).
boolean
C0221130 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0024299 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0020532 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Inclusion criteria Chronic Lymphocytic Leukemia
Item
inclusion criteria for cll:
boolean
C1512693 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Chronic Lymphocytic Leukemia Symptomatic Untreated | Binet Staging System | Rai Staging System | Patient need for Therapy
Item
the patient has previously confirmed (according to who criteria) untreated symptomatic chronic b-cell lymphocytic leukemia binet stage b or binet stage c or rai stage ii to iv in need of medical treatment.
boolean
C0023434 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C1511118 (UMLS CUI [2])
C1514715 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
ECOG performance status
Item
the patient has an eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial
Item
the patient has participated in a clinical study <30 days prior to the screening visit.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Patient Condition Quantity
Item
the patient has one or more of the following conditions:
boolean
C0030705 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Lymphoma transformation
Item
active transformed lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
Central nervous system lymphoma | Meningeal Lymphoma
Item
any history of central nervous system or leptomeningeal lymphoma
boolean
C0280803 (UMLS CUI [1])
C2213017 (UMLS CUI [2])
Cancer Other
Item
an active malignancy other than the target cancer within the past 5 years
boolean
C1707251 (UMLS CUI [1])
HIV
Item
human immunodeficiency virus
boolean
C0019682 (UMLS CUI [1])
Protocol Compliance Unlikely | Study Subject Participation Status Inappropriate
Item
the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Eligibility Criteria Additional
Item
other inclusion and exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial