ID

36316

Beskrivning

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01996865

Länk

https://clinicaltrials.gov/show/NCT01996865

Nyckelord

Versioner (1)
  1. 2019-05-02 2019-05-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT01996865

Engelsk

Eligibility Lymphoma, Non-Hodgkin NCT01996865

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
- age ≥18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed follicular lymphoma (grade 1, 2 or 3a), marginal zone lymphoma, or mantle cell lymphoma
Beskrivning

Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone Lymphoma | Mantle cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2]
C1367654
UMLS CUI [3]
C0334634
must have documented relapsed, refractory or progressive disease after last treatment with systemic therapy
Beskrivning

Recurrent disease | Refractory Disease | Progressive Disease | Status post Systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3]
C1335499
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1515119
bi-dimensionally measurable disease
Beskrivning

Measurable Disease 2-Dimensional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
eastern cooperative oncology group (ecog) performance status ≤ 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function
Beskrivning

Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
willingness to follow pregnancy precautions
Beskrivning

Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or grade 3b follicular lymphoma
Beskrivning

Histology Except Follicular Lymphoma | Histology Except Marginal Zone Lymphoma | Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0024301
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C1367654
UMLS CUI [3]
C0040682
UMLS CUI [4,1]
C0024301
UMLS CUI [4,2]
C0432516
any medical condition (other than the underlying lymphoma) that requires chronic steroid use
Beskrivning

Medical condition Requirement Steroid use chronic | Exception Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0281991
UMLS CUI [1,4]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024299
subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
Beskrivning

Adrenal Cortex Hormones | Exception Dose U/day | Exception Dose Equivalent Prednisone

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205163
UMLS CUI [3,4]
C0032952
systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
Beskrivning

Systemic therapy Lymphoma | Antibody therapy | Radioimmunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0024299
UMLS CUI [2]
C0281176
UMLS CUI [3]
C0085101
known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)
Beskrivning

Seropositive Hepatitis B Virus | Hepatitis B | Seropositive Hepatitis C virus | Hepatitis C | HIV Seropositivity | HIV Infections

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0521143
UMLS CUI [1,2]
C0019169
UMLS CUI [2]
C0019163
UMLS CUI [3,1]
C0521143
UMLS CUI [3,2]
C0220847
UMLS CUI [4]
C0019196
UMLS CUI [5]
C0019699
UMLS CUI [6]
C0019693
known sensitivity or allergy to murine products
Beskrivning

Hypersensitivity Products Murine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0026809
presence or history of central nervous system involvement by lymphoma. subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
Beskrivning

Central Nervous System Involvement with Lymphoma | At risk Thromboembolism | Prophylaxis Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0024299
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0040038
UMLS CUI [3,1]
C0199176
UMLS CUI [3,2]
C0558080
any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
Beskrivning

Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT01996865

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
- age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone Lymphoma | Mantle cell lymphoma
Item
histologically confirmed follicular lymphoma (grade 1, 2 or 3a), marginal zone lymphoma, or mantle cell lymphoma
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1367654 (UMLS CUI [2])
C0334634 (UMLS CUI [3])
Recurrent disease | Refractory Disease | Progressive Disease | Status post Systemic therapy
Item
must have documented relapsed, refractory or progressive disease after last treatment with systemic therapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C1515119 (UMLS CUI [4,2])
Measurable Disease 2-Dimensional
Item
bi-dimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function
Item
adequate bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Contraceptive methods
Item
willingness to follow pregnancy precautions
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Histology Except Follicular Lymphoma | Histology Except Marginal Zone Lymphoma | Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or grade 3b follicular lymphoma
boolean
C0344441 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0024301 (UMLS CUI [1,3])
C0344441 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C1367654 (UMLS CUI [2,3])
C0040682 (UMLS CUI [3])
C0024301 (UMLS CUI [4,1])
C0432516 (UMLS CUI [4,2])
Medical condition Requirement Steroid use chronic | Exception Lymphoma
Item
any medical condition (other than the underlying lymphoma) that requires chronic steroid use
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0281991 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0024299 (UMLS CUI [2,2])
Adrenal Cortex Hormones | Exception Dose U/day | Exception Dose Equivalent Prednisone
Item
subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
boolean
C0001617 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [3,3])
C0032952 (UMLS CUI [3,4])
Systemic therapy Lymphoma | Antibody therapy | Radioimmunotherapy
Item
systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
boolean
C1515119 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0281176 (UMLS CUI [2])
C0085101 (UMLS CUI [3])
Seropositive Hepatitis B Virus | Hepatitis B | Seropositive Hepatitis C virus | Hepatitis C | HIV Seropositivity | HIV Infections
Item
known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)
boolean
C0521143 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0521143 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C0019196 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
C0019693 (UMLS CUI [6])
Hypersensitivity Products Murine
Item
known sensitivity or allergy to murine products
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0026809 (UMLS CUI [1,3])
Central Nervous System Involvement with Lymphoma | At risk Thromboembolism | Prophylaxis Unwilling
Item
presence or history of central nervous system involvement by lymphoma. subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
boolean
C3714787 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
C1444641 (UMLS CUI [2,1])
C0040038 (UMLS CUI [2,2])
C0199176 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data
Item
any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
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