ID

35873

Beschreibung

Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Adults With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02258555

Link

https://clinicaltrials.gov/show/NCT02258555

Stichworte

Versionen (1)
  1. 31.03.19 31.03.19 -
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See clinicaltrials.gov

Hochgeladen am

31. März 2019

DOI

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Eligibility Follicular Lymphoma NCT02258555

Englisch

Eligibility Follicular Lymphoma NCT02258555

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of fl, mzl, sll, or cll (meeting international workshop on cll [iwcll] criteria, 2008) as documented by medical records and with histology based on criteria established by the world health organization
Beschreibung

Lymphoma, Follicular | Marginal Zone B-Cell Lymphoma | Small Lymphocytic Lymphoma | CLL

Datentyp

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C1367654
UMLS CUI [3]
C0855095
UMLS CUI [4]
C0023434
fl grades 1, 2, or 3a
Beschreibung

Follicular Lymphoma Ann Arbor lymphoma staging system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
sll with absolute lymphocyte count of < 5 x 10^9/l at initial diagnosis
Beschreibung

Small Lymphocytic Lymphoma | Absolute lymphocyte count

Datentyp

boolean

Alias
UMLS CUI [1]
C0855095
UMLS CUI [2]
C3544087
mzl (splenic, nodal, or extra-nodal)
Beschreibung

Splenic Marginal Zone B-Cell Lymphoma | Nodal marginal zone B-cell lymphoma | Extranodal marginal zone B-cell lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0349632
UMLS CUI [2]
C0242647
UMLS CUI [3]
C1955690
prior treatment for fl or cll/sll with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available
Beschreibung

Prior Therapy Follicular Lymphoma | Prior Therapy CLL | Prior Therapy Small Lymphocytic Lymphoma | Prior Chemotherapy Quantity | Prior Immunotherapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0024301
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0023434
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0855095
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C1514461
UMLS CUI [5,2]
C1265611
presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy
Beschreibung

Lymphadenopathy Measurable Radiography | Malignant lymphoid neoplasm Extranodal Measurable Radiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C0034571
UMLS CUI [2,1]
C0746336
UMLS CUI [2,2]
C1517067
UMLS CUI [2,3]
C1513040
UMLS CUI [2,4]
C0034571
all acute toxic effects of any prior antitumor therapy resolved to grade ≤1 before the start of study therapy (with the exception of alopecia [grade 1 or 2 permitted], or bone marrow parameters [any of grade 1, 2, or 3 permitted)
Beschreibung

Cancer treatment | Toxic effects Resolved CTCAE Grades | Exception Alopecia CTCAE Grades | Exception Bone Marrow parameters CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1514893
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0002170
UMLS CUI [3,3]
C1516728
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0005953
UMLS CUI [4,3]
C0449381
UMLS CUI [4,4]
C1516728
eastern cooperative oncology group (ecog) ≤ 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
able to provide written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of lymphoid malignancy other than fl, mzl, sll, or cll
Beschreibung

Malignant lymphoid neoplasm | Exception Follicular Lymphoma | Exception Marginal Zone B-Cell Lymphoma | Exception Small Lymphocytic Lymphoma | Exception CLL

Datentyp

boolean

Alias
UMLS CUI [1]
C0746336
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024301
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1367654
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0855095
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0023434
history of myelodysplastic syndrome
Beschreibung

MYELODYSPLASTIC SYNDROME

Datentyp

boolean

Alias
UMLS CUI [1]
C3463824
history of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years
Beschreibung

Malignant Neoplasms | Exception Malignant lymphoid neoplasm | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Superficial carcinoma of urinary bladder | Exception Prostate carcinoma Asymptomatic | Exception Prostate carcinoma Without Neoplasm Metastasis | Exception Prostate carcinoma Requirement Hormone Therapy | Exception Prostate carcinoma Prostate specific antigen normal | Exception Cancer Other In complete remission Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0746336
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1336527
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0600139
UMLS CUI [7,3]
C0231221
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0600139
UMLS CUI [8,3]
C0332288
UMLS CUI [8,4]
C0027627
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0600139
UMLS CUI [9,3]
C1514873
UMLS CUI [9,4]
C0279025
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0600139
UMLS CUI [10,3]
C0580554
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C1707251
UMLS CUI [11,3]
C0677874
UMLS CUI [11,4]
C0449238
evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy
Beschreibung

Systemic bacterial infection | Systemic mycosis | Systemic viral infection

Datentyp

boolean

Alias
UMLS CUI [1]
C4285778
UMLS CUI [2]
C0553576
UMLS CUI [3]
C4285789
ongoing drug-induced pneumonitis
Beschreibung

Drug-induced pneumonitis

Datentyp

boolean

Alias
UMLS CUI [1]
C1960026
ongoing inflammatory bowel disease
Beschreibung

Inflammatory Bowel Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0021390
history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Beschreibung

Bone Marrow Stem Cell Transplantation Allogeneic | Solid organ transplant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0842093
UMLS CUI [1,2]
C1515895
UMLS CUI [2]
C0730400
history of prior therapy with any inhibitor of serine/threonine kinase (akt), bruton tyrosine kinase (btk), janus kinase (jak), mammalian target of rapamycin (mtor), phosphatidylinositol 3-kinase (pi3k), or spleen tyrosine kinase (syk)
Beschreibung

AKT Inhibitor | IBTK | Janus kinase inhibitor | mTOR Inhibitor | Phosphatidylinositide 3-Kinase Inhibitor | SYK Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0812228
UMLS CUI [1,2]
C1999216
UMLS CUI [2]
C1425132
UMLS CUI [3]
C3854325
UMLS CUI [4]
C2746052
UMLS CUI [5]
C1519050
UMLS CUI [6,1]
C1335892
UMLS CUI [6,2]
C1999216
ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy
Beschreibung

Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE Malignant lymphoid neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2,1]
C3653708
UMLS CUI [2,2]
C0746336
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Ähnliche Modelle

Eligibility Follicular Lymphoma NCT02258555

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular | Marginal Zone B-Cell Lymphoma | Small Lymphocytic Lymphoma | CLL
Item
diagnosis of fl, mzl, sll, or cll (meeting international workshop on cll [iwcll] criteria, 2008) as documented by medical records and with histology based on criteria established by the world health organization
boolean
C0024301 (UMLS CUI [1])
C1367654 (UMLS CUI [2])
C0855095 (UMLS CUI [3])
C0023434 (UMLS CUI [4])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
fl grades 1, 2, or 3a
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Small Lymphocytic Lymphoma | Absolute lymphocyte count
Item
sll with absolute lymphocyte count of < 5 x 10^9/l at initial diagnosis
boolean
C0855095 (UMLS CUI [1])
C3544087 (UMLS CUI [2])
Splenic Marginal Zone B-Cell Lymphoma | Nodal marginal zone B-cell lymphoma | Extranodal marginal zone B-cell lymphoma
Item
mzl (splenic, nodal, or extra-nodal)
boolean
C0349632 (UMLS CUI [1])
C0242647 (UMLS CUI [2])
C1955690 (UMLS CUI [3])
Prior Therapy Follicular Lymphoma | Prior Therapy CLL | Prior Therapy Small Lymphocytic Lymphoma | Prior Chemotherapy Quantity | Prior Immunotherapy Quantity
Item
prior treatment for fl or cll/sll with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available
boolean
C1514463 (UMLS CUI [1,1])
C0024301 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0855095 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1514461 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
Lymphadenopathy Measurable Radiography | Malignant lymphoid neoplasm Extranodal Measurable Radiography
Item
presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy
boolean
C0497156 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0034571 (UMLS CUI [1,3])
C0746336 (UMLS CUI [2,1])
C1517067 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0034571 (UMLS CUI [2,4])
Cancer treatment | Toxic effects Resolved CTCAE Grades | Exception Alopecia CTCAE Grades | Exception Bone Marrow parameters CTCAE Grades
Item
all acute toxic effects of any prior antitumor therapy resolved to grade ≤1 before the start of study therapy (with the exception of alopecia [grade 1 or 2 permitted], or bone marrow parameters [any of grade 1, 2, or 3 permitted)
boolean
C0920425 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0002170 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0005953 (UMLS CUI [4,2])
C0449381 (UMLS CUI [4,3])
C1516728 (UMLS CUI [4,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant lymphoid neoplasm | Exception Follicular Lymphoma | Exception Marginal Zone B-Cell Lymphoma | Exception Small Lymphocytic Lymphoma | Exception CLL
Item
history of lymphoid malignancy other than fl, mzl, sll, or cll
boolean
C0746336 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024301 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1367654 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0855095 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0023434 (UMLS CUI [5,2])
MYELODYSPLASTIC SYNDROME
Item
history of myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
Malignant Neoplasms | Exception Malignant lymphoid neoplasm | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Superficial carcinoma of urinary bladder | Exception Prostate carcinoma Asymptomatic | Exception Prostate carcinoma Without Neoplasm Metastasis | Exception Prostate carcinoma Requirement Hormone Therapy | Exception Prostate carcinoma Prostate specific antigen normal | Exception Cancer Other In complete remission Duration
Item
history of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0746336 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1336527 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0600139 (UMLS CUI [7,2])
C0231221 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0600139 (UMLS CUI [8,2])
C0332288 (UMLS CUI [8,3])
C0027627 (UMLS CUI [8,4])
C1705847 (UMLS CUI [9,1])
C0600139 (UMLS CUI [9,2])
C1514873 (UMLS CUI [9,3])
C0279025 (UMLS CUI [9,4])
C1705847 (UMLS CUI [10,1])
C0600139 (UMLS CUI [10,2])
C0580554 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C1707251 (UMLS CUI [11,2])
C0677874 (UMLS CUI [11,3])
C0449238 (UMLS CUI [11,4])
Systemic bacterial infection | Systemic mycosis | Systemic viral infection
Item
evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy
boolean
C4285778 (UMLS CUI [1])
C0553576 (UMLS CUI [2])
C4285789 (UMLS CUI [3])
Drug-induced pneumonitis
Item
ongoing drug-induced pneumonitis
boolean
C1960026 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
ongoing inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Bone Marrow Stem Cell Transplantation Allogeneic | Solid organ transplant
Item
history of prior allogeneic bone marrow progenitor cell or solid organ transplantation
boolean
C0842093 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
C0730400 (UMLS CUI [2])
AKT Inhibitor | IBTK | Janus kinase inhibitor | mTOR Inhibitor | Phosphatidylinositide 3-Kinase Inhibitor | SYK Inhibitor
Item
history of prior therapy with any inhibitor of serine/threonine kinase (akt), bruton tyrosine kinase (btk), janus kinase (jak), mammalian target of rapamycin (mtor), phosphatidylinositol 3-kinase (pi3k), or spleen tyrosine kinase (syk)
boolean
C0812228 (UMLS CUI [1,1])
C1999216 (UMLS CUI [1,2])
C1425132 (UMLS CUI [2])
C3854325 (UMLS CUI [3])
C2746052 (UMLS CUI [4])
C1519050 (UMLS CUI [5])
C1335892 (UMLS CUI [6,1])
C1999216 (UMLS CUI [6,2])
Therapeutic immunosuppression | CORTICOSTEROIDS FOR SYSTEMIC USE Malignant lymphoid neoplasm
Item
ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy
boolean
C0021079 (UMLS CUI [1])
C3653708 (UMLS CUI [2,1])
C0746336 (UMLS CUI [2,2])
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