ID

40392

Beschrijving

A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO); ODM derived from: https://clinicaltrials.gov/show/NCT01882803

Link

https://clinicaltrials.gov/show/NCT01882803

Trefwoorden

Versies (1)
  1. 17-04-20 17-04-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 april 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Indolent Non-Hodgkin Lymphoma NCT01882803

Engels

Eligibility Indolent Non-Hodgkin Lymphoma NCT01882803

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who have been diagnosed with indolent nhl that has progressed.
Beschrijving

Indolent Non-Hodgkin Lymphoma progressed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1334170
UMLS CUI [1,2]
C1272688
subjects must have exhibited lack of cr or pr or progression within 6 months after the last dose of a chemotherapy induction regimen or rit.
Beschrijving

Complete remission Lacking | Partial response Lacking | Disease Progression | Status post Induction Chemotherapy | Status post Radioimmunotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C1521726
UMLS CUI [2,2]
C0332268
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C3179010
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0085101
subjects must have rituximab-refractory disease, defined as lack of cr or pr or pd within 6 months of last dose.
Beschrijving

Disease Unresponsive to Rituximab | Complete remission Lacking | Partial response Lacking | Progressive Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0393022
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0332268
UMLS CUI [4]
C1335499
measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by ct, pet/ct or mri.
Beschrijving

Measurable Disease CT | Measurable Disease PET/CT | Measurable Disease MRI | Nodal mass Size | Tumor Mass Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1699633
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0746921
UMLS CUI [4,2]
C0456389
UMLS CUI [5,1]
C3273930
UMLS CUI [5,2]
C0456389
adequate renal and hepatic function.
Beschrijving

Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
candidate for potentially curative therapies in the opinion of the investigator.
Beschrijving

Patient Appropriate Curative treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1273390
previous treatment with a pi3k inhibitor or btk inhibitor.
Beschrijving

PI3K Inhibitor | BTK Inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2,1]
C0218158
UMLS CUI [2,2]
C1999216
prior history of allogeneic hematopoietic stem cell transplant (hsct).
Beschrijving

Allogeneic Hematopoietic Stem Cell Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C1705576
prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
Beschrijving

Prior Chemotherapy | Therapeutic immunosuppression Malignant Neoplasms | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0006826
UMLS CUI [3]
C0013230
grade 3b fl and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
Beschrijving

Follicular Lymphoma Grade | Transformation Aggressive Lymphoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C1332225
symptomatic central nervous system (cns) nhl.
Beschrijving

CNS lymphoma Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0280803
UMLS CUI [1,2]
C0231220
ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
Beschrijving

Systemic bacterial infection | Systemic mycosis | Systemic viral infection

Datatype

boolean

Alias
UMLS CUI [1]
C4285778
UMLS CUI [2]
C0553576
UMLS CUI [3]
C4285789
prior, current, or chronic hepatitis b or hepatitis c infection, positive result for hepatitis c virus antibodies (hcv ab) or hepatitis b surface antigen (hbsag) or hepatitis b core antibodies (hbcab)
Beschrijving

Hepatitis B | Hepatitis C | Hepatitis B, Chronic | Hepatitis C, Chronic | Hepatitis C antibody positive | Hepatitis B surface antigen positive | Hepatitis B core antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0524909
UMLS CUI [4]
C0524910
UMLS CUI [5]
C0281863
UMLS CUI [6]
C0149709
UMLS CUI [7]
C0262506
history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug
Beschrijving

Cerebrovascular accident | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia Requirement Pharmaceutical Preparations | Ventricular arrhythmia Requirement Control

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0013227
UMLS CUI [5,1]
C0085612
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C2587213
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Similar models

Eligibility Indolent Non-Hodgkin Lymphoma NCT01882803

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Indolent Non-Hodgkin Lymphoma progressed
Item
subjects who have been diagnosed with indolent nhl that has progressed.
boolean
C1334170 (UMLS CUI [1,1])
C1272688 (UMLS CUI [1,2])
Complete remission Lacking | Partial response Lacking | Disease Progression | Status post Induction Chemotherapy | Status post Radioimmunotherapy
Item
subjects must have exhibited lack of cr or pr or progression within 6 months after the last dose of a chemotherapy induction regimen or rit.
boolean
C0677874 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C1521726 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C3179010 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0085101 (UMLS CUI [5,2])
Disease Unresponsive to Rituximab | Complete remission Lacking | Partial response Lacking | Progressive Disease
Item
subjects must have rituximab-refractory disease, defined as lack of cr or pr or pd within 6 months of last dose.
boolean
C0012634 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0393022 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1521726 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
C1335499 (UMLS CUI [4])
Measurable Disease CT | Measurable Disease PET/CT | Measurable Disease MRI | Nodal mass Size | Tumor Mass Size
Item
measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by ct, pet/ct or mri.
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1699633 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0746921 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C3273930 (UMLS CUI [5,1])
C0456389 (UMLS CUI [5,2])
Renal function | Liver function
Item
adequate renal and hepatic function.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Patient Appropriate Curative treatment
Item
candidate for potentially curative therapies in the opinion of the investigator.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
PI3K Inhibitor | BTK Inhibitor
Item
previous treatment with a pi3k inhibitor or btk inhibitor.
boolean
C1519050 (UMLS CUI [1])
C0218158 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
Allogeneic Hematopoietic Stem Cell Transplantation
Item
prior history of allogeneic hematopoietic stem cell transplant (hsct).
boolean
C1705576 (UMLS CUI [1])
Prior Chemotherapy | Therapeutic immunosuppression Malignant Neoplasms | Investigational New Drugs
Item
prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
boolean
C1514457 (UMLS CUI [1])
C0021079 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
Follicular Lymphoma Grade | Transformation Aggressive Lymphoma
Item
grade 3b fl and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0040682 (UMLS CUI [2,1])
C1332225 (UMLS CUI [2,2])
CNS lymphoma Symptomatic
Item
symptomatic central nervous system (cns) nhl.
boolean
C0280803 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Systemic bacterial infection | Systemic mycosis | Systemic viral infection
Item
ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
boolean
C4285778 (UMLS CUI [1])
C0553576 (UMLS CUI [2])
C4285789 (UMLS CUI [3])
Hepatitis B | Hepatitis C | Hepatitis B, Chronic | Hepatitis C, Chronic | Hepatitis C antibody positive | Hepatitis B surface antigen positive | Hepatitis B core antibody positive
Item
prior, current, or chronic hepatitis b or hepatitis c infection, positive result for hepatitis c virus antibodies (hcv ab) or hepatitis b surface antigen (hbsag) or hepatitis b core antibodies (hbcab)
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0524909 (UMLS CUI [3])
C0524910 (UMLS CUI [4])
C0281863 (UMLS CUI [5])
C0149709 (UMLS CUI [6])
C0262506 (UMLS CUI [7])
Cerebrovascular accident | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia Requirement Pharmaceutical Preparations | Ventricular arrhythmia Requirement Control
Item
history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug
boolean
C0038454 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0085612 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C2587213 (UMLS CUI [5,3])
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