ID

41233

Description

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT02017613

Link

https://clinicaltrials.gov/show/NCT02017613

Keywords

Versions (1)
  1. 7/21/20 7/21/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 21, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, B-Cell NCT02017613

English

Eligibility Lymphoma, B-Cell NCT02017613

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
refractory to or relapsed after at least 1 prior treatment line.
Description

Unresponsive to Treatment | Recurrent disease | Status post Therapeutic procedure Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0205269
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C1265611
ecog performance status ≤2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must be ≥18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
able to give a written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any cancer therapy in the last 4 weeks or limited palliative radiation <2 weeks
Description

Cancer treatment | Palliative course of radiotherapy Limited

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0475092
UMLS CUI [2,2]
C0439801
patients with hbv, hcv or hiv infection
Description

Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
autologous hematologic stem cell transplant within 3 months of study entry. allogeneic hematologic stem cell transplant within 12 months.
Description

Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C2193200
UMLS CUI [2]
C4255274
previous therapy with gs-1101 (cal-101, idelalisib), ipi-145, tgr-1202 or any drug that specifically inhibits pi3k/ mtor (including temsirolimus, everolimus), akt or btk inhibitor (including ibrutinib).
Description

GS-1101 | CAL 101 | idelalisib | IPI-145 | TGR-1202 | Phosphatidylinositide 3-Kinase Inhibitor | mTOR Inhibitor | temsirolimus | everolimus | AKT Inhibitor | BTK Inhibitor | ibrutinib

Data type

boolean

Alias
UMLS CUI [1]
C3529624
UMLS CUI [2]
C2703131
UMLS CUI [3]
C2698692
UMLS CUI [4]
C3274621
UMLS CUI [5]
C3641791
UMLS CUI [6]
C1519050
UMLS CUI [7]
C2746052
UMLS CUI [8]
C1707080
UMLS CUI [9]
C0541315
UMLS CUI [10]
C4744361
UMLS CUI [11]
C4086017
UMLS CUI [12]
C3501358
patients on immunosuppressive therapy including systemic corticosteroids.
Description

Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C3653708
patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
Description

Anticoagulation Therapy Systemic chronic | warfarin | sodium | heparin

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205191
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0037473
UMLS CUI [4]
C0019134
patients with known history of liver disorders.
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
patients with uncontrolled diabetes type i or type ii
Description

Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C2732402
UMLS CUI [2]
C2733146
any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
Description

Other medical condition Severe Affecting Study Subject Participation Status | Other medical condition Uncontrolled Affecting Study Subject Participation Status | Condition Affecting Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2348568
women who are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Lymphoma, B-Cell NCT02017613

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Unresponsive to Treatment | Recurrent disease | Status post Therapeutic procedure Quantity
Item
refractory to or relapsed after at least 1 prior treatment line.
boolean
C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
ECOG performance status
Item
ecog performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Age
Item
patients must be ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to give a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment | Palliative course of radiotherapy Limited
Item
any cancer therapy in the last 4 weeks or limited palliative radiation <2 weeks
boolean
C0920425 (UMLS CUI [1])
C0475092 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Hepatitis B | Hepatitis C | HIV Infection
Item
patients with hbv, hcv or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant
Item
autologous hematologic stem cell transplant within 3 months of study entry. allogeneic hematologic stem cell transplant within 12 months.
boolean
C2193200 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
GS-1101 | CAL 101 | idelalisib | IPI-145 | TGR-1202 | Phosphatidylinositide 3-Kinase Inhibitor | mTOR Inhibitor | temsirolimus | everolimus | AKT Inhibitor | BTK Inhibitor | ibrutinib
Item
previous therapy with gs-1101 (cal-101, idelalisib), ipi-145, tgr-1202 or any drug that specifically inhibits pi3k/ mtor (including temsirolimus, everolimus), akt or btk inhibitor (including ibrutinib).
boolean
C3529624 (UMLS CUI [1])
C2703131 (UMLS CUI [2])
C2698692 (UMLS CUI [3])
C3274621 (UMLS CUI [4])
C3641791 (UMLS CUI [5])
C1519050 (UMLS CUI [6])
C2746052 (UMLS CUI [7])
C1707080 (UMLS CUI [8])
C0541315 (UMLS CUI [9])
C4744361 (UMLS CUI [10])
C4086017 (UMLS CUI [11])
C3501358 (UMLS CUI [12])
Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
patients on immunosuppressive therapy including systemic corticosteroids.
boolean
C0021079 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Anticoagulation Therapy Systemic chronic | warfarin | sodium | heparin
Item
patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
boolean
C0003281 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2])
C0037473 (UMLS CUI [3])
C0019134 (UMLS CUI [4])
Liver disease
Item
patients with known history of liver disorders.
boolean
C0023895 (UMLS CUI [1])
Type 1 diabetes mellitus uncontrolled | Type II diabetes mellitus uncontrolled
Item
patients with uncontrolled diabetes type i or type ii
boolean
C2732402 (UMLS CUI [1])
C2733146 (UMLS CUI [2])
Other medical condition Severe Affecting Study Subject Participation Status | Other medical condition Uncontrolled Affecting Study Subject Participation Status | Condition Affecting Study Subject Participation Status
Item
any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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