ID

36315

Descrição

An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02413489

Link

https://clinicaltrials.gov/show/NCT02413489

Palavras-chave

Versões (1)
  1. 02/05/2019 02/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma, Mantle-Cell NCT02413489

Inglês

Eligibility Lymphoma, Mantle-Cell NCT02413489

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
has diagnosis and prior treatment for each non-hodgkin's lymphoma (nhl) subtype as defined below: mantle cell lymphoma (mcl): pathologically verified diagnosis of mcl based on local pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy, including at least one cycle of ibrutinib therapy and documented progressive disease (pd) during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events [aes]), b) diffuse large b cell lymphoma (dlbcl): pathologically confirmed diagnosis of non-transformed dlbcl, and c) relapsed or refractory disease; participants are not eligible or considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac), c) follicular lymphoma (fl): pathologically confirmed diagnosis of fl of grade 1, 2, or 3a according to world health organization (who) criteria without pathological evidence of transformation, and relapsed disease after at least two prior systemic therapies including one anti-cd20 containing combination regimen
Descrição

Non-Hodgkin Lymphoma Subtype | Mantle cell lymphoma | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Status post Therapeutic procedure Quantity | Ibrutinib | Progressive Disease | Intolerance to Ibrutinib | Ibrutinib Discontinued Due to Adverse event | Diffuse Large B-Cell Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Ineligibility High-dose chemotherapy | Ineligibility Transplantation of autologous hematopoietic stem cell | Etiology Organ dysfunction | Etiology Comorbidity | Etiology Comorbidity pulmonary | Etiology Comorbidity cardiac | Follicular Lymphoma WHO tumor classification | Transformation Absent | Recurrent Follicular Lymphoma | Status post Systemic therapy Quantity | Status post Combined Modality Therapy Containing Anti-CD20 Antibody

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C0449560
UMLS CUI [2]
C0334634
UMLS CUI [3]
C0677725
UMLS CUI [4]
C0855138
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C1265611
UMLS CUI [6]
C3501358
UMLS CUI [7]
C1335499
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C3501358
UMLS CUI [9,1]
C3501358
UMLS CUI [9,2]
C1444662
UMLS CUI [9,3]
C0678226
UMLS CUI [9,4]
C0877248
UMLS CUI [10]
C0079744
UMLS CUI [11]
C0855111
UMLS CUI [12]
C0855112
UMLS CUI [13,1]
C1512714
UMLS CUI [13,2]
C1328050
UMLS CUI [14,1]
C1512714
UMLS CUI [14,2]
C1831743
UMLS CUI [15,1]
C0015127
UMLS CUI [15,2]
C0349410
UMLS CUI [16,1]
C0015127
UMLS CUI [16,2]
C0009488
UMLS CUI [17,1]
C0015127
UMLS CUI [17,2]
C0009488
UMLS CUI [17,3]
C0024109
UMLS CUI [18,1]
C0015127
UMLS CUI [18,2]
C0009488
UMLS CUI [18,3]
C0018787
UMLS CUI [19,1]
C0024301
UMLS CUI [19,2]
C1301142
UMLS CUI [20,1]
C0040682
UMLS CUI [20,2]
C0332197
UMLS CUI [21]
C1335701
UMLS CUI [22,1]
C0231290
UMLS CUI [22,2]
C1515119
UMLS CUI [22,3]
C1265611
UMLS CUI [23,1]
C0231290
UMLS CUI [23,2]
C0009429
UMLS CUI [23,3]
C0332256
UMLS CUI [23,4]
C3891557
at least 1 measurable site of disease
Descrição

Measurable Disease Site Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
expression of cd38 by immunohistochemistry on fresh or archived tumor sample by central assessment: a) stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for cd38, b) stage 2: participants whose tumors are >=1% positive for cd38
Descrição

Tumor tissue sample CD38 Gene Expression Immunohistochemistry | Tumor Cell positive for CD38 antigen Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C1413221
UMLS CUI [1,3]
C0017262
UMLS CUI [1,4]
C0021044
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0945928
UMLS CUI [2,3]
C0439165
participant must have an ecog performance status score of 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. a woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to cycle 1 day 1. a man who is sexually active with a woman of childbearing potential must agree to always use condom during sexual intercourse, and all men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug
Descrição

Childbearing Potential Sexual Abstinence Heterosexual | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Gender Partner in relationship Childbearing Potential | Gender Sexually active Condom use | Gender Sperm donation Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [1,3]
C0019421
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C3831118
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C0679782
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0871414
UMLS CUI [7,3]
C0332197
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known central nervous system lymphoma
Descrição

Central nervous system lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0742472
prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
Descrição

Cancer treatment | Nitrosoureas | Chemotherapy | Antibody therapy | Radioimmunoconjugates | Toxin Immunoconjugates | Therapeutic radiology procedure | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0028210
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0281176
UMLS CUI [5]
C0243019
UMLS CUI [6,1]
C0040549
UMLS CUI [6,2]
C0243020
UMLS CUI [7]
C1522449
UMLS CUI [8]
C0013230
daratumumab or other anti-cd38 therapies
Descrição

daratumumab | Therapy Against CD38

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2346801
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0075742
participant has a history of malignancy (other than nhl) within 5 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
Descrição

Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Invasive carcinoma of urinary bladder | Exception Papillary neoplasm of low malignant potential | Exception Primary tumor Non-invasive | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024305
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1827293
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0476073
UMLS CUI [7,3]
C0154129
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0677930
UMLS CUI [8,3]
C0205303
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0006826
UMLS CUI [9,3]
C1880198
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C4528387
UMLS CUI [10,3]
C0034897
participant has known chronic obstructive pulmonary disease (copd) with a forced expiratory volume in 1 second (fev1) less than (<) 50% predicted normal. note that fev1 testing is required for patients suspected of having copd and participants must be excluded if fev1 <50% b) participant has known moderate or severe persistent asthma within 2 years (see attachment 4: nhlbi table of asthma severity), or currently has uncontrolled asthma of any classification. (note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
Descrição

Chronic Obstructive Airway Disease | Percent predicted FEV1 | Moderate persistent asthma | Severe persistent asthma | Asthma Uncontrolled | Intermittent asthma Controlled allowed | Mild persistent asthma Controlled allowed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0730561
UMLS CUI [3]
C1960047
UMLS CUI [4]
C1960048
UMLS CUI [5,1]
C0004096
UMLS CUI [5,2]
C0205318
UMLS CUI [6,1]
C1740754
UMLS CUI [6,2]
C2911690
UMLS CUI [6,3]
C0683607
UMLS CUI [7,1]
C1960046
UMLS CUI [7,2]
C2911690
UMLS CUI [7,3]
C0683607
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Similar models

Eligibility Lymphoma, Mantle-Cell NCT02413489

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin Lymphoma Subtype | Mantle cell lymphoma | Mantle cell lymphoma recurrent | Mantle cell lymphoma refractory | Status post Therapeutic procedure Quantity | Ibrutinib | Progressive Disease | Intolerance to Ibrutinib | Ibrutinib Discontinued Due to Adverse event | Diffuse Large B-Cell Lymphoma | Diffuse large B-cell lymphoma recurrent | Diffuse large B-cell lymphoma refractory | Ineligibility High-dose chemotherapy | Ineligibility Transplantation of autologous hematopoietic stem cell | Etiology Organ dysfunction | Etiology Comorbidity | Etiology Comorbidity pulmonary | Etiology Comorbidity cardiac | Follicular Lymphoma WHO tumor classification | Transformation Absent | Recurrent Follicular Lymphoma | Status post Systemic therapy Quantity | Status post Combined Modality Therapy Containing Anti-CD20 Antibody
Item
has diagnosis and prior treatment for each non-hodgkin's lymphoma (nhl) subtype as defined below: mantle cell lymphoma (mcl): pathologically verified diagnosis of mcl based on local pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy, including at least one cycle of ibrutinib therapy and documented progressive disease (pd) during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events [aes]), b) diffuse large b cell lymphoma (dlbcl): pathologically confirmed diagnosis of non-transformed dlbcl, and c) relapsed or refractory disease; participants are not eligible or considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac), c) follicular lymphoma (fl): pathologically confirmed diagnosis of fl of grade 1, 2, or 3a according to world health organization (who) criteria without pathological evidence of transformation, and relapsed disease after at least two prior systemic therapies including one anti-cd20 containing combination regimen
boolean
C0024305 (UMLS CUI [1,1])
C0449560 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2])
C0677725 (UMLS CUI [3])
C0855138 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C3501358 (UMLS CUI [6])
C1335499 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C3501358 (UMLS CUI [8,2])
C3501358 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
C0678226 (UMLS CUI [9,3])
C0877248 (UMLS CUI [9,4])
C0079744 (UMLS CUI [10])
C0855111 (UMLS CUI [11])
C0855112 (UMLS CUI [12])
C1512714 (UMLS CUI [13,1])
C1328050 (UMLS CUI [13,2])
C1512714 (UMLS CUI [14,1])
C1831743 (UMLS CUI [14,2])
C0015127 (UMLS CUI [15,1])
C0349410 (UMLS CUI [15,2])
C0015127 (UMLS CUI [16,1])
C0009488 (UMLS CUI [16,2])
C0015127 (UMLS CUI [17,1])
C0009488 (UMLS CUI [17,2])
C0024109 (UMLS CUI [17,3])
C0015127 (UMLS CUI [18,1])
C0009488 (UMLS CUI [18,2])
C0018787 (UMLS CUI [18,3])
C0024301 (UMLS CUI [19,1])
C1301142 (UMLS CUI [19,2])
C0040682 (UMLS CUI [20,1])
C0332197 (UMLS CUI [20,2])
C1335701 (UMLS CUI [21])
C0231290 (UMLS CUI [22,1])
C1515119 (UMLS CUI [22,2])
C1265611 (UMLS CUI [22,3])
C0231290 (UMLS CUI [23,1])
C0009429 (UMLS CUI [23,2])
C0332256 (UMLS CUI [23,3])
C3891557 (UMLS CUI [23,4])
Measurable Disease Site Quantity
Item
at least 1 measurable site of disease
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Tumor tissue sample CD38 Gene Expression Immunohistochemistry | Tumor Cell positive for CD38 antigen Percentage
Item
expression of cd38 by immunohistochemistry on fresh or archived tumor sample by central assessment: a) stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for cd38, b) stage 2: participants whose tumors are >=1% positive for cd38
boolean
C0475358 (UMLS CUI [1,1])
C1413221 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C0945928 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
ECOG performance status
Item
participant must have an ecog performance status score of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Sexual Abstinence Heterosexual | Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Gender Partner in relationship Childbearing Potential | Gender Sexually active Condom use | Gender Sperm donation Absent
Item
women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. a woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to cycle 1 day 1. a man who is sexually active with a woman of childbearing potential must agree to always use condom during sexual intercourse, and all men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0019421 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C3831118 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0679782 (UMLS CUI [6,3])
C0079399 (UMLS CUI [7,1])
C0871414 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Central nervous system lymphoma
Item
known central nervous system lymphoma
boolean
C0742472 (UMLS CUI [1])
Cancer treatment | Nitrosoureas | Chemotherapy | Antibody therapy | Radioimmunoconjugates | Toxin Immunoconjugates | Therapeutic radiology procedure | Investigational New Drugs
Item
prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks
boolean
C0920425 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0281176 (UMLS CUI [4])
C0243019 (UMLS CUI [5])
C0040549 (UMLS CUI [6,1])
C0243020 (UMLS CUI [6,2])
C1522449 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
daratumumab | Therapy Against CD38
Item
daratumumab or other anti-cd38 therapies
boolean
C2346801 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0075742 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Non-Hodgkin Lymphoma | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Invasive carcinoma of urinary bladder | Exception Papillary neoplasm of low malignant potential | Exception Primary tumor Non-invasive | Exception Malignant Neoplasm Cured | Exception Minimal Risk Recurrence
Item
participant has a history of malignancy (other than nhl) within 5 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0024305 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1827293 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0476073 (UMLS CUI [7,2])
C0154129 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0677930 (UMLS CUI [8,2])
C0205303 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0006826 (UMLS CUI [9,2])
C1880198 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C4528387 (UMLS CUI [10,2])
C0034897 (UMLS CUI [10,3])
Chronic Obstructive Airway Disease | Percent predicted FEV1 | Moderate persistent asthma | Severe persistent asthma | Asthma Uncontrolled | Intermittent asthma Controlled allowed | Mild persistent asthma Controlled allowed
Item
participant has known chronic obstructive pulmonary disease (copd) with a forced expiratory volume in 1 second (fev1) less than (<) 50% predicted normal. note that fev1 testing is required for patients suspected of having copd and participants must be excluded if fev1 <50% b) participant has known moderate or severe persistent asthma within 2 years (see attachment 4: nhlbi table of asthma severity), or currently has uncontrolled asthma of any classification. (note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
boolean
C0024117 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
C1960047 (UMLS CUI [3])
C1960048 (UMLS CUI [4])
C0004096 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C1740754 (UMLS CUI [6,1])
C2911690 (UMLS CUI [6,2])
C0683607 (UMLS CUI [6,3])
C1960046 (UMLS CUI [7,1])
C2911690 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
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