ID

41207

Beschreibung

A Study of MK-4827 for the Treatment of Mantle Cell Lymphoma (MK-4827-002); ODM derived from: https://clinicaltrials.gov/show/NCT01244009

Link

https://clinicaltrials.gov/show/NCT01244009

Stichworte

Versionen (1)
  1. 14.07.20 14.07.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. Juli 2020

DOI

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Eligibility Lymphoma NCT01244009

Englisch

Eligibility Lymphoma NCT01244009

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01244009
Criteria
Beschreibung

Criteria

participant must have a diagnosis of mcl that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
Beschreibung

Mantle cell lymphoma recurrent | Status post Prior Chemotherapy Quantity | Standard of Care Refused

Datentyp

boolean

Alias
UMLS CUI [1]
C0677725
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1514457
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C1705116
participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. at least one lesion must be > 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
Beschreibung

Measurable Disease | Lymphadenopathy | Organomegaly | Bone Marrow Involvement | Circulating Neoplastic Cells Lymphoma | Lesion Quantity Longest Diameter | Measurable lesion 2-Dimensional

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0497156
UMLS CUI [3]
C4054315
UMLS CUI [4]
C1517677
UMLS CUI [5,1]
C0027625
UMLS CUI [5,2]
C0024299
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0552406
UMLS CUI [7,1]
C1513041
UMLS CUI [7,2]
C1705052
participant has a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) performance scale
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
Beschreibung

Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
male participants agree to use an adequate method of contraception throughout the study
Beschreibung

Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence
Beschreibung

History of malignant neoplasm Absent | Exception Cervix carcinoma Special | Exception Skin carcinoma | Exception Prostate carcinoma Special | Exception Curative treatment | Exception Recurrence Absent | Exception Low risk Recurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0455471
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0302592
UMLS CUI [2,3]
C0205555
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0600139
UMLS CUI [4,3]
C0205555
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0034897
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C5201228
UMLS CUI [7,3]
C0034897
participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment
Beschreibung

Platelet Transfusion Absent | Red Blood Cell Transfusion Absent | Colony-Stimulating Factor Support Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0086252
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0009392
UMLS CUI [3,2]
C0344211
UMLS CUI [3,3]
C0332197
participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available
Beschreibung

Availability of Tumor tissue sample Formalin-Fixed Paraffin-Embedded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C4684951
exclusion criteria :
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Biological treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
participant has a history of central nervous system (cns) lymphoma
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0280803
participant requires the use of corticosteroids
Beschreibung

Adrenal Cortex Hormones Required

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1514873
participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Reproduction Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0035150
UMLS CUI [4,2]
C1301732
participant is known to be human immunodeficiency virus (hiv)-positive
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
participant has a history of hepatitis b or c
Beschreibung

Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Ähnliche Modelle

Eligibility Lymphoma NCT01244009

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01244009
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Mantle cell lymphoma recurrent | Status post Prior Chemotherapy Quantity | Standard of Care Refused
Item
participant must have a diagnosis of mcl that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy
boolean
C0677725 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2936643 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Measurable Disease | Lymphadenopathy | Organomegaly | Bone Marrow Involvement | Circulating Neoplastic Cells Lymphoma | Lesion Quantity Longest Diameter | Measurable lesion 2-Dimensional
Item
participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. at least one lesion must be > 2 cm in the longest diameter and measurable in 2 perpendicular dimensions
boolean
C1513041 (UMLS CUI [1])
C0497156 (UMLS CUI [2])
C4054315 (UMLS CUI [3])
C1517677 (UMLS CUI [4])
C0027625 (UMLS CUI [5,1])
C0024299 (UMLS CUI [5,2])
C0221198 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0552406 (UMLS CUI [6,3])
C1513041 (UMLS CUI [7,1])
C1705052 (UMLS CUI [7,2])
ECOG performance status
Item
participant has a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) performance scale
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity | Childbearing Potential Sexual Abstinence
Item
female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
Gender Contraceptive methods
Item
male participants agree to use an adequate method of contraception throughout the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
History of malignant neoplasm Absent | Exception Cervix carcinoma Special | Exception Skin carcinoma | Exception Prostate carcinoma Special | Exception Curative treatment | Exception Recurrence Absent | Exception Low risk Recurrence
Item
participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence
boolean
C0455471 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0302592 (UMLS CUI [2,2])
C0205555 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0205555 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0034897 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C5201228 (UMLS CUI [7,2])
C0034897 (UMLS CUI [7,3])
Platelet Transfusion Absent | Red Blood Cell Transfusion Absent | Colony-Stimulating Factor Support Absent
Item
participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment
boolean
C0086818 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0086252 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009392 (UMLS CUI [3,1])
C0344211 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Availability of Tumor tissue sample Formalin-Fixed Paraffin-Embedded
Item
participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C4684951 (UMLS CUI [1,3])
Exclusion Criteria
Item
exclusion criteria :
boolean
C0680251 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Biological treatment
Item
participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
Central nervous system lymphoma
Item
participant has a history of central nervous system (cns) lymphoma
boolean
C0280803 (UMLS CUI [1])
Adrenal Cortex Hormones Required
Item
participant requires the use of corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Reproduction Planned
Item
participant is pregnant, breastfeeding, or expecting to conceive or father children during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0035150 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
HIV Seropositivity
Item
participant is known to be human immunodeficiency virus (hiv)-positive
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
participant has a history of hepatitis b or c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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