ID

35191

Beschreibung

A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO); ODM derived from: https://clinicaltrials.gov/show/NCT02391545

Link

https://clinicaltrials.gov/show/NCT02391545

Stichworte

Versionen (1)
  1. 23.02.19 23.02.19 -
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See clinicaltrials.gov

Hochgeladen am

23. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility CD20+ Follicular Lymphoma NCT02391545

Englisch

Eligibility CD20+ Follicular Lymphoma NCT02391545

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of cd20+, follicular lymphoma that has not been treated
Beschreibung

Follicular Lymphoma CD20 positive Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C0332155
cd20-immunophenotyping of tumor to document b-cell follicular lymphoma
Beschreibung

CD20 Tumor immunophenotyping status | Lymphoma, Follicular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C1300074
UMLS CUI [2]
C0024301
stage ii disease with bulky disease (≥ 7cm lesion), stage iii, or stage iv disease
Beschreibung

Disease Ann Arbor lymphoma staging system | Bulky Disease Lesion size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
UMLS CUI [2,1]
C1511341
UMLS CUI [2,2]
C0449453
disease that requires treatment based on the investigator's opinion (e.g., meets gelf criteria)
Beschreibung

Disease Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332121
at least one measurable lesion that is > 1.5 cm in at least one dimension
Beschreibung

Measurable lesion | Lesion size Dimension Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
eastern cooperative oncology group (ecog) performance status <=2 (corresponds to karnofsky performance status [kps] >=60%)
Beschreibung

ECOG performance status | Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
Beschreibung

Systemic therapy Lymphoma | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational New Drugs | Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0024299
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0013230
UMLS CUI [6]
C0085101
clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma
Beschreibung

Transformation Lymphoma Subtype Aggressive | Transformation Follicular Lymphoma Grade

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C0024299
UMLS CUI [1,3]
C0449560
UMLS CUI [1,4]
C0580822
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C0024301
UMLS CUI [2,3]
C0441800
severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
Beschreibung

Severe allergic reaction Monoclonal Antibody Therapy | Anaphylactic reaction Severe Monoclonal Antibody Therapy | Severe allergic reaction Murine protein | Anaphylactic reaction Severe Murine protein | Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2220378
UMLS CUI [1,2]
C0279694
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0279694
UMLS CUI [3,1]
C2220378
UMLS CUI [3,2]
C1699668
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1699668
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013230
prior allogeneic hematopoietic stem cell transplant
Beschreibung

Allogeneic Hematopoietic Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C1705576
prior, current or chronic hepatitis b or hepatitis c infection
Beschreibung

Hepatitis B | Hepatitis C | Hepatitis B, Chronic | Hepatitis C, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0524910
human immunodeficiency virus (hiv) infection or human t cell lymphotropic virus 1 (htlv-1) infection
Beschreibung

HIV Infection | HTLV-I Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0020097
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Ähnliche Modelle

Eligibility CD20+ Follicular Lymphoma NCT02391545

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma CD20 positive Untreated
Item
diagnosis of cd20+, follicular lymphoma that has not been treated
boolean
C0024301 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
CD20 Tumor immunophenotyping status | Lymphoma, Follicular
Item
cd20-immunophenotyping of tumor to document b-cell follicular lymphoma
boolean
C0054946 (UMLS CUI [1,1])
C1300074 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2])
Disease Ann Arbor lymphoma staging system | Bulky Disease Lesion size
Item
stage ii disease with bulky disease (≥ 7cm lesion), stage iii, or stage iv disease
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1511341 (UMLS CUI [2,1])
C0449453 (UMLS CUI [2,2])
Disease Treatment required for
Item
disease that requires treatment based on the investigator's opinion (e.g., meets gelf criteria)
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Measurable lesion | Lesion size Dimension Quantity
Item
at least one measurable lesion that is > 1.5 cm in at least one dimension
boolean
C1513041 (UMLS CUI [1])
C0449453 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status <=2 (corresponds to karnofsky performance status [kps] >=60%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systemic therapy Lymphoma | Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational New Drugs | Radioimmunotherapy
Item
received systemic treatment for lymphoma such as chemotherapy, immunotherapy, radiotherapy, investigational agents, or radioimmunotherapy.
boolean
C1515119 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
C0085101 (UMLS CUI [6])
Transformation Lymphoma Subtype Aggressive | Transformation Follicular Lymphoma Grade
Item
clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma
boolean
C0040682 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0449560 (UMLS CUI [1,3])
C0580822 (UMLS CUI [1,4])
C0040682 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
C0441800 (UMLS CUI [2,3])
Severe allergic reaction Monoclonal Antibody Therapy | Anaphylactic reaction Severe Monoclonal Antibody Therapy | Severe allergic reaction Murine protein | Anaphylactic reaction Severe Murine protein | Hypersensitivity Investigational New Drugs
Item
severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
boolean
C2220378 (UMLS CUI [1,1])
C0279694 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0279694 (UMLS CUI [2,3])
C2220378 (UMLS CUI [3,1])
C1699668 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1699668 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
Allogeneic Hematopoietic Stem Cell Transplantation
Item
prior allogeneic hematopoietic stem cell transplant
boolean
C1705576 (UMLS CUI [1])
Hepatitis B | Hepatitis C | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
prior, current or chronic hepatitis b or hepatitis c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
HIV Infection | HTLV-I Infection
Item
human immunodeficiency virus (hiv) infection or human t cell lymphotropic virus 1 (htlv-1) infection
boolean
C0019693 (UMLS CUI [1])
C0020097 (UMLS CUI [2])
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