ID

41217

Descrição

Phase I Study of Romidepsin Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01590732

Link

https://clinicaltrials.gov/show/NCT01590732

Palavras-chave

Versões (1)
  1. 18/07/2020 18/07/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

18 de julho de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma NCT01590732

Inglês

Eligibility Lymphoma NCT01590732

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01590732
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. relapsed or refractory tcl status including diagnoses of peripheral tcl-nos, angioimmunoblastic tcl, anaplastic large cell lymphoma, hepatosplenic tcl, enteropathy-associated tcl, or mycosis fungoides(mf)/cutaneous tcl with transformation to systemic tcl.
Descrição

T-cell lymphoma recurrent | T-cell lymphoma refractory | Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphadenopathy | Anaplastic large B-cell lymphoma | Hepatosplenic T-cell lymphoma | Enteropathy-Associated T-Cell Lymphoma | Lymphoma, T-Cell, Cutaneous | Mycosis fungoides with systemic infiltration

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0854826
UMLS CUI [2]
C0854827
UMLS CUI [3]
C0079774
UMLS CUI [4]
C0020981
UMLS CUI [5]
C1321546
UMLS CUI [6]
C1333984
UMLS CUI [7]
C0456889
UMLS CUI [8]
C0079773
UMLS CUI [9]
C1275305
2. patients must have received at least one chemotherapy regimen which contained doxorubicin.
Descrição

Chemotherapy Quantity | doxorubicin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0013089
3. at least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of tcl.
Descrição

Measurable lesion 2-Dimensional Quantity | Bone Marrow T-Cell Lymphoma Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0079772
UMLS CUI [2,3]
C1514241
4. eastern cooperative oncology group (ecog) performance status </= 2.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
5. lab criteria of absolute neutrophil count (anc) >/= 1000 cells/mm3, platelets >/= 80,000 cells/mm3 if baseline bone marrow negative for tcl involvement and platelets >/= 20,000 cells/mm3 if baseline bone marrow positive for tcl involvement, bilirubin </= 2 x upper limits of normal (uln) (gilbert's </= 3 x uln), creatinine </= 1.5 x uln, and alt and ast </= 3 x uln.
Descrição

Absolute neutrophil count | Platelet Count measurement | Bone Marrow Negative T-Cell Lymphoma | Bone Marrow Positive T-Cell Lymphoma | Serum total bilirubin measurement | Gilbert Disease | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C1513916
UMLS CUI [3,3]
C0079772
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C1514241
UMLS CUI [4,3]
C0079772
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0017551
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201899
6. negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment.
Descrição

Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods | Hormonal Contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Condoms | Spermatocidal Agents | Sexual Abstinence

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0677582
UMLS CUI [7]
C0037862
UMLS CUI [8]
C0036899
7. age of >/= 18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
8. voluntarily signed institutional review board (irb) approved informed consent document (icd) before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of another malignancy not in remission for at least 2 yrs (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)
Descrição

Cancer Other | Remission Absent | Exception Skin carcinoma | Exception Melanoma TNM clinical staging | Exception Prostate carcinoma Localized | Exception Cervical cancer In situ

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0687702
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0025202
UMLS CUI [4,3]
C3258246
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C0392752
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C4048328
UMLS CUI [6,3]
C0444498
2. known active central nervous system (cns) lymphoma.
Descrição

Primary central nervous system lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0280803
3. ejection fraction (ef) of < 40%, myocardial infarction (mi) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ecg evidence of acute ischemia.
Descrição

Cardiac ejection fraction | Myocardial Infarction | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | ECG myocardial ischemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5]
C0474715
4. grade 3 infection within 2 weeks of first dose romidepsin plus ice.
Descrição

Communicable Disease CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1516728
5. pregnant or lactating.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. receipt of another investigational drug within 14 days of enrollment.
Descrição

Investigational New Drugs Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
7. patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone).
Descrição

Allergic Reaction Investigational New Drugs | Allergic Reaction Investigational New Drug Component | Exception Podophyllum preparation | Exception povidone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1110663
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0032856
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Similar models

Eligibility Lymphoma NCT01590732

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01590732
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
T-cell lymphoma recurrent | T-cell lymphoma refractory | Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphadenopathy | Anaplastic large B-cell lymphoma | Hepatosplenic T-cell lymphoma | Enteropathy-Associated T-Cell Lymphoma | Lymphoma, T-Cell, Cutaneous | Mycosis fungoides with systemic infiltration
Item
1. relapsed or refractory tcl status including diagnoses of peripheral tcl-nos, angioimmunoblastic tcl, anaplastic large cell lymphoma, hepatosplenic tcl, enteropathy-associated tcl, or mycosis fungoides(mf)/cutaneous tcl with transformation to systemic tcl.
boolean
C0854826 (UMLS CUI [1])
C0854827 (UMLS CUI [2])
C0079774 (UMLS CUI [3])
C0020981 (UMLS CUI [4])
C1321546 (UMLS CUI [5])
C1333984 (UMLS CUI [6])
C0456889 (UMLS CUI [7])
C0079773 (UMLS CUI [8])
C1275305 (UMLS CUI [9])
Chemotherapy Quantity | doxorubicin
Item
2. patients must have received at least one chemotherapy regimen which contained doxorubicin.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0013089 (UMLS CUI [2])
Measurable lesion 2-Dimensional Quantity | Bone Marrow T-Cell Lymphoma Positive
Item
3. at least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of tcl.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0005953 (UMLS CUI [2,1])
C0079772 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement | Bone Marrow Negative T-Cell Lymphoma | Bone Marrow Positive T-Cell Lymphoma | Serum total bilirubin measurement | Gilbert Disease | Creatinine measurement, serum | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. lab criteria of absolute neutrophil count (anc) >/= 1000 cells/mm3, platelets >/= 80,000 cells/mm3 if baseline bone marrow negative for tcl involvement and platelets >/= 20,000 cells/mm3 if baseline bone marrow positive for tcl involvement, bilirubin </= 2 x upper limits of normal (uln) (gilbert's </= 3 x uln), creatinine </= 1.5 x uln, and alt and ast </= 3 x uln.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0079772 (UMLS CUI [3,3])
C0005953 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0079772 (UMLS CUI [4,3])
C1278039 (UMLS CUI [5])
C0017551 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
Childbearing Potential Pregnancy test negative | Females & males of reproductive potential Contraceptive methods | Hormonal Contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Condoms | Spermatocidal Agents | Sexual Abstinence
Item
6. negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C4034483 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0677582 (UMLS CUI [6])
C0037862 (UMLS CUI [7])
C0036899 (UMLS CUI [8])
Age
Item
7. age of >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
8. voluntarily signed institutional review board (irb) approved informed consent document (icd) before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Remission Absent | Exception Skin carcinoma | Exception Melanoma TNM clinical staging | Exception Prostate carcinoma Localized | Exception Cervical cancer In situ
Item
1. history of another malignancy not in remission for at least 2 yrs (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)
boolean
C1707251 (UMLS CUI [1])
C0687702 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0025202 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C0392752 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C4048328 (UMLS CUI [6,2])
C0444498 (UMLS CUI [6,3])
Primary central nervous system lymphoma
Item
2. known active central nervous system (cns) lymphoma.
boolean
C0280803 (UMLS CUI [1])
Cardiac ejection fraction | Myocardial Infarction | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | ECG myocardial ischemia
Item
3. ejection fraction (ef) of < 40%, myocardial infarction (mi) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrythmias, or ecg evidence of acute ischemia.
boolean
C0232174 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0474715 (UMLS CUI [5])
Communicable Disease CTCAE Grades
Item
4. grade 3 infection within 2 weeks of first dose romidepsin plus ice.
boolean
C0009450 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
5. pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs Other
Item
6. receipt of another investigational drug within 14 days of enrollment.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Allergic Reaction Investigational New Drugs | Allergic Reaction Investigational New Drug Component | Exception Podophyllum preparation | Exception povidone
Item
7. patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone).
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1110663 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0032856 (UMLS CUI [4,2])
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