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ID

14565

Beschreibung

Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01031368

Link

https://clinicaltrials.gov/show/NCT01031368

Stichworte

Versionen (1)
  1. 21.04.16 21.04.16 -
Hochgeladen am

21. April 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01031368

    Englisch

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01031368

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    cohort a: diagnosis of aml by world health organization (who) criteria, either relapsed or refractory; acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and variants] will be eligible only after failure of a regimen containing arsenic trioxide; patients in this cohort must have had an initial remission duration of < 1 year and cannot have received any prior salvage chemotherapy
    Beschreibung

    aml

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    cohort b: untreated aml patients, excluding those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
    Beschreibung

    untreated aml

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0332155
    cohort c: untreated aml patients, including those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
    Beschreibung

    untreated aml

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [1,3]
    C0010802
    the first three patients enrolled in cohorts a and b must be less than 60 years old; thereafter, patients aged >= 18 and =< 70 are eligible
    Beschreibung

    age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    the first three patients enrolled in cohorts a and b must have an eastern cooperative oncology group (ecog) performance status of 0 -1; thereafter, ecog performance status of 0-2 is required
    Beschreibung

    eastern cooperative oncology group (ecog) performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    serum creatinine =< 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age in years)^-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
    Beschreibung

    serum creatinine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    serum total bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is thought to be due to gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
    Beschreibung

    serum total bilirubin

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 2.5 x uln, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
    Beschreibung

    aspartate aminotransferase

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    alkaline phosphatase =< 2.5 x uln
    Beschreibung

    alkaline phosphatase

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1561546
    capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
    Beschreibung

    negative serum pregnancy test

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0430061
    male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
    Beschreibung

    Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    allogeneic transplant recipients
    Beschreibung

    allogeneic transplant

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149615
    cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
    Beschreibung

    chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0021081
    UMLS CUI [1,4]
    C0199974
    have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease), or other organ system dysfunction
    Beschreibung

    concurrent disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
    Beschreibung

    systemic infection and inflammation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3646020
    pregnant or lactating patients
    Beschreibung

    pregnant or lactating

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0549206
    UMLS CUI [1,2]
    C0006147
    any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
    Beschreibung

    compliance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0009488
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01031368

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    aml
    Item
    cohort a: diagnosis of aml by world health organization (who) criteria, either relapsed or refractory; acute promyelocytic leukemia [acute promyelocytic leukemia with t(15;17)(q22;q12) and variants] will be eligible only after failure of a regimen containing arsenic trioxide; patients in this cohort must have had an initial remission duration of < 1 year and cannot have received any prior salvage chemotherapy
    boolean
    C0023467 (UMLS CUI [1])
    untreated aml
    Item
    cohort b: untreated aml patients, excluding those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
    boolean
    C0023467 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    untreated aml
    Item
    cohort c: untreated aml patients, including those with favorable cytogenetic or molecular abnormalities per the european leukemianet recommendations
    boolean
    C0023467 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0010802 (UMLS CUI [1,3])
    age
    Item
    the first three patients enrolled in cohorts a and b must be less than 60 years old; thereafter, patients aged >= 18 and =< 70 are eligible
    boolean
    C0001779 (UMLS CUI [1])
    eastern cooperative oncology group (ecog) performance status
    Item
    the first three patients enrolled in cohorts a and b must have an eastern cooperative oncology group (ecog) performance status of 0 -1; thereafter, ecog performance status of 0-2 is required
    boolean
    C1520224 (UMLS CUI [1])
    serum creatinine
    Item
    serum creatinine =< 1.0 mg/dl; if serum creatinine > 1.0 mg/dl, then the estimated glomerular filtration rate (gfr) must be > 60 ml/min/1.73 m^2 as calculated by the modification of diet in renal disease equation where predicted gfr (ml/min/1.73 m^2) = 186 x (serum creatinine)^-1.154 x (age in years)^-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
    boolean
    C0201976 (UMLS CUI [1])
    serum total bilirubin
    Item
    serum total bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is thought to be due to gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
    boolean
    C1278039 (UMLS CUI [1])
    aspartate aminotransferase
    Item
    aspartate aminotransferase (ast)/alanine aminotransferase (alt) =< 2.5 x uln, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
    boolean
    C0201899 (UMLS CUI [1])
    alkaline phosphatase
    Item
    alkaline phosphatase =< 2.5 x uln
    boolean
    C1561546 (UMLS CUI [1])
    informed consent
    Item
    capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
    boolean
    C0021430 (UMLS CUI [1])
    negative serum pregnancy test
    Item
    female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
    boolean
    C0430061 (UMLS CUI [1])
    Contraceptive methods
    Item
    male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment
    boolean
    C0700589 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    allogeneic transplant
    Item
    allogeneic transplant recipients
    boolean
    C0149615 (UMLS CUI [1])
    chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
    Item
    cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
    boolean
    C0392920 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0021081 (UMLS CUI [1,3])
    C0199974 (UMLS CUI [1,4])
    concurrent disease
    Item
    have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease), or other organ system dysfunction
    boolean
    C0009488 (UMLS CUI [1])
    systemic infection and inflammation
    Item
    patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
    boolean
    C3646020 (UMLS CUI [1])
    pregnant or lactating
    Item
    pregnant or lactating patients
    boolean
    C0549206 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    compliance
    Item
    any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
    boolean
    C0525058 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    Zum Seitenanfang zurückkehren 

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