0 Ratings
ID

12651

Description

A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL; ODM derived from: https://clinicaltrials.gov/show/NCT01439347

Link

https://clinicaltrials.gov/show/NCT01439347

Keywords

Versions (1)
  1. 12/7/15 12/7/15 -
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December 7, 2015

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Creative Commons BY 4.0
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    Eligibility Acute Lymphoblastic Leukemia (ALL) NCT01439347

    English

    Eligibility Acute Lymphoblastic Leukemia (ALL) NCT01439347

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    have provided written, signed, and dated informed consent to participate in the study, in accordance with the ich gcp guideline e6 and all applicable local regulations.are age >or=60 years (at the time of providing informed consent).
    Description

    have provided written, signed, and dated informed consent to participate in the study, in accordance with the ich gcp guideline e6 and all applicable local regulations.are age >or=60 years

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0001779
    have newly diagnosed, histologically proven, untreated philadelphia chromosome-negative (ph-) all, with >or= 5% bone marrow blasts.
    Description

    have newly diagnosed, histologically proven, untreated philadelphia chromosome-negative (ph-) all

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023449
    have an eastern cooperative oncology group (ecog) performance status of 0-2. have a life expectancy >or= 3 months.
    Description

    have an eastern cooperative oncology group (ecog) performance status of 0-2. have a life expectancy >or= 3 months

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0023671
    have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:
    Description

    have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0232741
    total bilirubin ≤ 2.0 x the upper limit of normal (uln), unless the subject has a known diagnosis of gilbert's disease aspartate transaminase (ast, sgot) or alanine transaminase (alt, sgpt) ≤ 3 x uln serum creatinine ≤ 1.5 x uln. not have had major surgery within 4 weeks before the planned start of treatment.
    Description

    total bilirubin ≤ 2.0 x the upper limit of normal (uln), unless the subject has a known diagnosis of gilbert's disease aspartate transaminase (ast, sgot) or alanine transaminase (alt, sgpt) ≤ 3 x uln serum creatinine ≤ 1.5 x uln. not have had major surgery within 4 weeks before the planned start of treatment.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201913
    UMLS CUI [2]
    C1287351
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C0679637
    if female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.
    Description

    if female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    if male and sexually active with a partner of child-bearing potential, agree to use an acceptable barrier method for contraception from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.
    Description

    contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    have the ability and willingness to fully comply with study procedures and restrictions.
    Description

    compliance behavior

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    has had prior systemic chemotherapy (for all or other malignancy). has had prior vincristine for any reason. is planning to undergo stem cell transplantation (sct) as any part of first-line therapy for all.
    Description

    has had prior systemic chemotherapy (for all or other malignancy). has had prior vincristine for any reason. is planning to undergo stem cell transplantation (sct) as any part of first-line therapy for all

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1883256
    UMLS CUI [2]
    C1504389
    has burkitts lymphoma/leukemia. has philadelphia chromosome-positive (ph+) all and/or bcr/abl rearrangements documented by fluorescent in-situ hybridization (fish), cytogenetics, or polymerase chain reaction (pcr).
    Description

    has burkitts lymphoma/leukemia. has philadelphia chromosome-positive (ph+) all and/or bcr/abl rearrangements documented by fluorescent in-situ hybridization (fish), cytogenetics, or polymerase chain reaction (pcr).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006413
    UMLS CUI [2]
    C1960397
    has active central nervous system (cns) disease. has ongoing neuropathy of any etiology > grade 1. has a history of persistent active neurologic disorders including demyelinating form of charcot-marie-tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
    Description

    has active central nervous system (cns) disease. has ongoing neuropathy of any etiology > grade 1. has a history of persistent active neurologic disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007682
    UMLS CUI [2]
    C0027765
    UMLS CUI [3]
    C0442874
    prior hydroxyurea (hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on day 5 of induction).
    Description

    prior hydroxyurea (hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on day 5 of induction).

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020402
    has received prior steroids within 7 days before beginning protocol-specified induction therapy for reasons other than leukocytosis (steroids for the management of leukocytosis are allowed but must be planned to be tapered off before or on day 5 of induction).
    Description

    steroid therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0149783
    has an active serious infection not controlled by oral or iv antibiotics or antifungals.
    Description

    Infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    has received any investigational therapy within 28 days before beginning any protocol-defined chemotherapeutic treatment.
    Description

    study subject participation status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Acute Lymphoblastic Leukemia (ALL) NCT01439347

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    have provided written, signed, and dated informed consent to participate in the study, in accordance with the ich gcp guideline e6 and all applicable local regulations.are age >or=60 years
    Item
    have provided written, signed, and dated informed consent to participate in the study, in accordance with the ich gcp guideline e6 and all applicable local regulations.are age >or=60 years (at the time of providing informed consent).
    boolean
    C0021430 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    have newly diagnosed, histologically proven, untreated philadelphia chromosome-negative (ph-) all
    Item
    have newly diagnosed, histologically proven, untreated philadelphia chromosome-negative (ph-) all, with >or= 5% bone marrow blasts.
    boolean
    C0023449 (UMLS CUI [1])
    have an eastern cooperative oncology group (ecog) performance status of 0-2. have a life expectancy >or= 3 months
    Item
    have an eastern cooperative oncology group (ecog) performance status of 0-2. have a life expectancy >or= 3 months.
    boolean
    C1520224 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:
    Item
    have renal and liver function as defined below within 14 days, inclusive, prior to study enrollment, unless the abnormality is considered attributable to leukemia:
    boolean
    C0232804 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    total bilirubin ≤ 2.0 x the upper limit of normal (uln), unless the subject has a known diagnosis of gilbert's disease aspartate transaminase (ast, sgot) or alanine transaminase (alt, sgpt) ≤ 3 x uln serum creatinine ≤ 1.5 x uln. not have had major surgery within 4 weeks before the planned start of treatment.
    Item
    total bilirubin ≤ 2.0 x the upper limit of normal (uln), unless the subject has a known diagnosis of gilbert's disease aspartate transaminase (ast, sgot) or alanine transaminase (alt, sgpt) ≤ 3 x uln serum creatinine ≤ 1.5 x uln. not have had major surgery within 4 weeks before the planned start of treatment.
    boolean
    C0201913 (UMLS CUI [1])
    C1287351 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C0679637 (UMLS CUI [4])
    if female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control
    Item
    if female, are post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.
    boolean
    C0700589 (UMLS CUI [1])
    contraceptive methods
    Item
    if male and sexually active with a partner of child-bearing potential, agree to use an acceptable barrier method for contraception from the screening visit through 30 days after the last dose of any protocol defined chemotherapeutic agents.
    boolean
    C0700589 (UMLS CUI [1])
    compliance behavior
    Item
    have the ability and willingness to fully comply with study procedures and restrictions.
    boolean
    C1321605 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    has had prior systemic chemotherapy (for all or other malignancy). has had prior vincristine for any reason. is planning to undergo stem cell transplantation (sct) as any part of first-line therapy for all
    Item
    has had prior systemic chemotherapy (for all or other malignancy). has had prior vincristine for any reason. is planning to undergo stem cell transplantation (sct) as any part of first-line therapy for all.
    boolean
    C1883256 (UMLS CUI [1])
    C1504389 (UMLS CUI [2])
    has burkitts lymphoma/leukemia. has philadelphia chromosome-positive (ph+) all and/or bcr/abl rearrangements documented by fluorescent in-situ hybridization (fish), cytogenetics, or polymerase chain reaction (pcr).
    Item
    has burkitts lymphoma/leukemia. has philadelphia chromosome-positive (ph+) all and/or bcr/abl rearrangements documented by fluorescent in-situ hybridization (fish), cytogenetics, or polymerase chain reaction (pcr).
    boolean
    C0006413 (UMLS CUI [1])
    C1960397 (UMLS CUI [2])
    has active central nervous system (cns) disease. has ongoing neuropathy of any etiology > grade 1. has a history of persistent active neurologic disorders
    Item
    has active central nervous system (cns) disease. has ongoing neuropathy of any etiology > grade 1. has a history of persistent active neurologic disorders including demyelinating form of charcot-marie-tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions.
    boolean
    C0007682 (UMLS CUI [1])
    C0027765 (UMLS CUI [2])
    C0442874 (UMLS CUI [3])
    prior hydroxyurea (hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on day 5 of induction).
    Item
    prior hydroxyurea (hydrea®) for the management of any condition other than leukocytosis or prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for the management of leukocytosis must be planned to be tapered off before or on day 5 of induction).
    boolean
    C0020402 (UMLS CUI [1])
    steroid therapy
    Item
    has received prior steroids within 7 days before beginning protocol-specified induction therapy for reasons other than leukocytosis (steroids for the management of leukocytosis are allowed but must be planned to be tapered off before or on day 5 of induction).
    boolean
    C0149783 (UMLS CUI [1])
    Infection
    Item
    has an active serious infection not controlled by oral or iv antibiotics or antifungals.
    boolean
    C0009450 (UMLS CUI [1])
    study subject participation status
    Item
    has received any investigational therapy within 28 days before beginning any protocol-defined chemotherapeutic treatment.
    boolean
    C2348568 (UMLS CUI [1])
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