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41102

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02096042

Stichworte

Versionen (1)
  1. 24/6/20 24/6/20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24 de junio de 2020

DOI

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    Eligibility Leukemia NCT02096042

    Englisch

    Eligibility Leukemia NCT02096042

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02096042
    Inclusion Criteria
    Beschreibung

    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.
    Beschreibung

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

    Datentyp

    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+
    Beschreibung

    AML Blasts CD30 expression | Flow Cytometry

    Datentyp

    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)
    Beschreibung

    CD30 expression Immunohistochemistry

    Datentyp

    boolean

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

    Age

    Datentyp

    boolean

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

    ECOG performance status

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Gender Contraceptive methods | Gender Partner Childbearing Potential

    Datentyp

    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.
    Beschreibung

    Informed Consent | Informed Consent Patient Representative

    Datentyp

    boolean

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

    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).
    Beschreibung

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

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    Cerebral disorder | Meningeal disorder

    Datentyp

    boolean

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

    Targeted Therapy Against CD30

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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.
    Beschreibung

    Communicable Diseases Uncontrolled | Virus Diseases | Bacterial Infections | Mycoses

    Datentyp

    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
    Beschreibung

    Hepatitis B | Hepatitis B surface antigen positive

    Datentyp

    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)
    Beschreibung

    Hepatitis C positive Polymerase Chain Reaction | Antiviral Therapy Hepatitis C

    Datentyp

    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
    Beschreibung

    Peripheral Neuropathy Pre-existing CTCAE Grades

    Datentyp

    boolean

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

    Diabetic - poor control

    Datentyp

    boolean

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

    Antineoplastic Agents Systemic | Antineoplastic Agents Investigational

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

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

    Hypersensitivity Excipient Brentuximab vedotin

    Datentyp

    boolean

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

    Leukoencephalopathy, Progressive Multifocal

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023524
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    Ähnliche Modelle

    Eligibility Leukemia NCT02096042

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT02096042
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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