ID

12651

Descrição

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

Palavras-chave

Versões (1)
  1. 07/12/2015 07/12/2015 -
Transferido a

7 de dezembro de 2015

DOI

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Licença

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

Inglês

Eligibility Acute Lymphoblastic Leukemia (ALL) NCT01439347

1 Formulários  
Inclusion Criteria
Descrição

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).
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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:
Descrição

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

Tipo de dados

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.
Descrição

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.

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

contraceptive methods

Tipo de dados

boolean

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

compliance behavior

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Descrição

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.
Descrição

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

Tipo de dados

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).
Descrição

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).

Tipo de dados

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.
Descrição

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

Tipo de dados

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).
Descrição

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).

Tipo de dados

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).
Descrição

steroid therapy

Tipo de dados

boolean

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

Infection

Tipo de dados

boolean

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

study subject participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Acute Lymphoblastic Leukemia (ALL) NCT01439347

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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