ID

41102

Beskrivning

Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT02096042

Länk

https://clinicaltrials.gov/show/NCT02096042

Nyckelord

Versioner (1)
  1. 2020-06-24 2020-06-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT02096042

Engelsk

Eligibility Leukemia NCT02096042

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02096042
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed aml, other than acute promyelocytic leukemia, as defined by the 2008 world health organization (who) criteria that is relapsed or refractory to standard chemotherapy. note: newly-diagnosed aml patients who are 60 years or older and are not candidates for or have refused standard chemotherapy are also eligible for this trial.
Beskrivning

Leukemia, Myelocytic, Acute | Exception Acute Promyelocytic Leukemia | Recurrent Acute Myeloid Leukemia | Unresponsive to Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023487
UMLS CUI [3]
C1142169
UMLS CUI [4,1]
C0205269
UMLS CUI [4,2]
C0392920
2. aml blasts must express cd30 (>/=10% expression as assessed by flow-cytometry or 2+
Beskrivning

AML Blasts CD30 expression | Flow Cytometry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0368761
UMLS CUI [1,3]
C3888510
UMLS CUI [2]
C0016263
expression by immunohistochemistry) (whenever possible cd30 expression will be assessed by both methods)
Beskrivning

CD30 expression Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3888510
UMLS CUI [1,2]
C0021044
3. age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. eastern cooperative oncology group (ecog) performance status score of </=3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. the following baseline laboratory data: serum bilirubin </=1.5 x upper limit of normal (uln) or </= 3 x uln for patients with gilbert's disease; serum creatinine </=1.5 x uln and creatinine clearance >30 ml/min; alanine aminotransferase (alt) and aspartate aminotransferase (ast) </=3 x uln
Beskrivning

Laboratory Results | Serum total bilirubin measurement | Relationship Gilbert Disease | Creatinine measurement, serum | Creatinine clearance measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C1278039
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0017551
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201899
6. females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hcg) pregnancy test result within 14 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
Beskrivning

Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine hCG pregnancy test Negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C2188702
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
7. males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
Beskrivning

Gender Contraceptive methods | Gender Partner Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C3831118
8. patients or their legally authorized representative must provide written informed consent.
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
Beskrivning

Cancer Other Invasive Untreated | Remission Absent | Exception Skin carcinoma | Exception Carcinoma in Situ

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0677874
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007099
2. documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with new york heart association class iii-iv within 6 months prior to their first dose of brentuximab vedotin
Beskrivning

Event Cerebrovascular | Cerebrovascular accident | Transient Ischemic Attack | Angina, Unstable | Myocardial Infarction | Cardiac symptom New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1880018
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0741933
UMLS CUI [6,2]
C1275491
3. evidence of active cerebral/meningeal disease. patients may have history of cns leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration.
Beskrivning

Cerebral disorder | Meningeal disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0234387
UMLS CUI [2]
C0154728
4. previous treatment with any anti-cd30 directed therapy
Beskrivning

Targeted Therapy Against CD30

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0054950
5. patients with previous allogeneic stem cell transplant (sct) if they meet either of the following criteria: <100 days from allogeneic sct, acute or chronic graft-versus-host disease (gvhd), or receiving immunosuppressive therapy as treatment for or prophylaxis against gvhd within the last 7 days
Beskrivning

Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Chronic graft-versus-host disease | Therapeutic immunosuppression Graft-vs-Host Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2]
C0018133
UMLS CUI [3]
C0867389
UMLS CUI [4,1]
C0021079
UMLS CUI [4,2]
C0018133
6. patients with uncontrolled active infections (viral, bacterial, and fungal) are not eligible.
Beskrivning

Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0004623
UMLS CUI [4]
C0026946
7. known to be positive for hepatitis b by surface antigen expression
Beskrivning

Hepatitis B | Hepatitis B surface antigen positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0149709
8. known to have active hepatitis c infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis c within the last 6 months)
Beskrivning

Hepatitis C positive Polymerase Chain Reaction | Antiviral Therapy Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1112419
UMLS CUI [1,2]
C0032520
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0019196
9. preexisting grade >/=2 peripheral neuropathy
Beskrivning

Peripheral Neuropathy Pre-existing CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
10. patients with uncontrolled diabetes mellitus
Beskrivning

Diabetic - poor control

Datatyp

boolean

Alias
UMLS CUI [1]
C0421258
11. current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.
Beskrivning

Antineoplastic Agents Systemic | Antineoplastic Agents Investigational

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1517586
12. chemotherapy (except hydroxyurea or emergent use of single-agent cytarabine for cytoreduction), radiotherapy, biologics, and/or other treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug, unless progressive disease is documented. note: hydroxyurea will be allowed during the first cycle of treatment
Beskrivning

Chemotherapy | Exception Hydroxyurea | Exception Cytarabine Cytoreduction | Therapeutic radiology procedure | Biological treatment | Immunotherapy | Exception Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020402
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0010711
UMLS CUI [3,3]
C0864494
UMLS CUI [4]
C1522449
UMLS CUI [5]
C1531518
UMLS CUI [6]
C0021083
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1335499
13. females who are pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
14. known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin
Beskrivning

Hypersensitivity Excipient Brentuximab vedotin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0015237
UMLS CUI [1,3]
C2973446
15. history of progressive multifocal leukoencephalopathy (pml)
Beskrivning

Leukoencephalopathy, Progressive Multifocal

Datatyp

boolean

Alias
UMLS CUI [1]
C0023524
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Similar models

Eligibility Leukemia NCT02096042

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02096042
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | Exception Acute Promyelocytic Leukemia | Recurrent Acute Myeloid Leukemia | Unresponsive to Chemotherapy
Item
1. histologically or cytologically confirmed aml, other than acute promyelocytic leukemia, as defined by the 2008 world health organization (who) criteria that is relapsed or refractory to standard chemotherapy. note: newly-diagnosed aml patients who are 60 years or older and are not candidates for or have refused standard chemotherapy are also eligible for this trial.
boolean
C0023467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0023487 (UMLS CUI [2,2])
C1142169 (UMLS CUI [3])
C0205269 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
AML Blasts CD30 expression | Flow Cytometry
Item
2. aml blasts must express cd30 (>/=10% expression as assessed by flow-cytometry or 2+
boolean
C0023467 (UMLS CUI [1,1])
C0368761 (UMLS CUI [1,2])
C3888510 (UMLS CUI [1,3])
C0016263 (UMLS CUI [2])
CD30 expression Immunohistochemistry
Item
expression by immunohistochemistry) (whenever possible cd30 expression will be assessed by both methods)
boolean
C3888510 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Age
Item
3. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status score of </=3
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Serum total bilirubin measurement | Relationship Gilbert Disease | Creatinine measurement, serum | Creatinine clearance measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. the following baseline laboratory data: serum bilirubin </=1.5 x upper limit of normal (uln) or </= 3 x uln for patients with gilbert's disease; serum creatinine </=1.5 x uln and creatinine clearance >30 ml/min; alanine aminotransferase (alt) and aspartate aminotransferase (ast) </=3 x uln
boolean
C1254595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0017551 (UMLS CUI [3,2])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
Childbearing Potential Serum pregnancy test (B-HCG) Negative | Childbearing Potential Urine hCG pregnancy test Negative | Childbearing Potential Contraceptive methods
Item
6. females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hcg) pregnancy test result within 14 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C2188702 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Gender Contraceptive methods | Gender Partner Childbearing Potential
Item
7. males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
8. patients or their legally authorized representative must provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other Invasive Untreated | Remission Absent | Exception Skin carcinoma | Exception Carcinoma in Situ
Item
1. history of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses).
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0677874 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
Event Cerebrovascular | Cerebrovascular accident | Transient Ischemic Attack | Angina, Unstable | Myocardial Infarction | Cardiac symptom New York Heart Association Classification
Item
2. documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with new york heart association class iii-iv within 6 months prior to their first dose of brentuximab vedotin
boolean
C0441471 (UMLS CUI [1,1])
C1880018 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0741933 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
Cerebral disorder | Meningeal disorder
Item
3. evidence of active cerebral/meningeal disease. patients may have history of cns leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of registration.
boolean
C0234387 (UMLS CUI [1])
C0154728 (UMLS CUI [2])
Targeted Therapy Against CD30
Item
4. previous treatment with any anti-cd30 directed therapy
boolean
C2985566 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0054950 (UMLS CUI [1,3])
Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease | Chronic graft-versus-host disease | Therapeutic immunosuppression Graft-vs-Host Disease
Item
5. patients with previous allogeneic stem cell transplant (sct) if they meet either of the following criteria: <100 days from allogeneic sct, acute or chronic graft-versus-host disease (gvhd), or receiving immunosuppressive therapy as treatment for or prophylaxis against gvhd within the last 7 days
boolean
C4255274 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
C0867389 (UMLS CUI [3])
C0021079 (UMLS CUI [4,1])
C0018133 (UMLS CUI [4,2])
Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses
Item
6. patients with uncontrolled active infections (viral, bacterial, and fungal) are not eligible.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2])
C0004623 (UMLS CUI [3])
C0026946 (UMLS CUI [4])
Hepatitis B | Hepatitis B surface antigen positive
Item
7. known to be positive for hepatitis b by surface antigen expression
boolean
C0019163 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Hepatitis C positive Polymerase Chain Reaction | Antiviral Therapy Hepatitis C
Item
8. known to have active hepatitis c infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis c within the last 6 months)
boolean
C1112419 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Peripheral Neuropathy Pre-existing CTCAE Grades
Item
9. preexisting grade >/=2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Diabetic - poor control
Item
10. patients with uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Antineoplastic Agents Systemic | Antineoplastic Agents Investigational
Item
11. current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents.
boolean
C0003392 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Chemotherapy | Exception Hydroxyurea | Exception Cytarabine Cytoreduction | Therapeutic radiology procedure | Biological treatment | Immunotherapy | Exception Progressive Disease
Item
12. chemotherapy (except hydroxyurea or emergent use of single-agent cytarabine for cytoreduction), radiotherapy, biologics, and/or other treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug, unless progressive disease is documented. note: hydroxyurea will be allowed during the first cycle of treatment
boolean
C0392920 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020402 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0010711 (UMLS CUI [3,2])
C0864494 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C1335499 (UMLS CUI [7,2])
Pregnancy | Breast Feeding
Item
13. females who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Excipient Brentuximab vedotin
Item
14. known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin
boolean
C0020517 (UMLS CUI [1,1])
C0015237 (UMLS CUI [1,2])
C2973446 (UMLS CUI [1,3])
Leukoencephalopathy, Progressive Multifocal
Item
15. history of progressive multifocal leukoencephalopathy (pml)
boolean
C0023524 (UMLS CUI [1])
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