0 Ratings
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

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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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