ID

13253

Beschreibung

Dasatinib (Sprycel™) in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00850382

Link

https://clinicaltrials.gov/show/NCT00850382

Stichworte

Versionen (1)
  1. 26.01.16 26.01.16 -
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26. Januar 2016

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Eligibility Acute Myeloid Leukemia (AML) DRKS00003753 NCT00850382

Englisch

Eligibility Acute Myeloid Leukemia (AML) NCT00850382

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
core binding factor (cbf) aml with molecular diagnosis of runx1-runx1t1 fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or of cbfb-myh11 fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) as assessed in one of the central amlsg reference laboratories.
Beschreibung

AML

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
age ≥ 18; there is no upper age limit.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
no prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diag-nostic screening phase.
Beschreibung

chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
non-pregnant and non-nursing. due to the unknown teratogenic potential of dasatinib in humans, pregnant or nursing patients may not be enrolled. women of childbearing poten-tial (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration. women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (e.g., iud, hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - at the same time, at least four weeks before she begins dasatinib therapy. "women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
Beschreibung

pregnancy, lactation and contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
men must agree not to father a child and must use a latex condom during any sexual con-tact with women of childbearing potential while taking dasatinib and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy.
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
signed written informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
performance status who >2
Beschreibung

who performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
pulmonary edema and/or pleural/pericardial effusion within 14 days of day 1. if edema/effusion resolves to ctc grade ≤ 1, patients can be treated with dasatinib.
Beschreibung

pulmonary edema and/or pleural/pericardial effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0034063
UMLS CUI [2]
C0032227
patients with ejection fraction < 50% by echocardiography within 14 days of day 1
Beschreibung

ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, ast or ap >2.5x upper normal serum level; heart failure nyha iii/iv; severe obstructive or restrictive ventilation disorder)
Beschreibung

organ insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0002594
UMLS CUI [4]
C1275491
UMLS CUI [5]
C0024115
uncontrolled infection
Beschreibung

infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
severe neurological or psychiatric disorder interfering with ability of giving an informed consent
Beschreibung

neurological or psychiatric disorder interfering with ability of giving an informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
known positive for hiv
Beschreibung

HIV

Datentyp

boolean

Alias
UMLS CUI [1]
C0019682
bleeding disorder independent of leukemia
Beschreibung

bleeding disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
no consent for registration, storage and processing of the individual disease-characteristics and course
Beschreibung

no consent for registration, storage and processing of the individual disease-characteristics and course

Datentyp

boolean

Alias
UMLS CUI [1]
C1511481
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Ähnliche Modelle

Eligibility Acute Myeloid Leukemia (AML) NCT00850382

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
core binding factor (cbf) aml with molecular diagnosis of runx1-runx1t1 fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or of cbfb-myh11 fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) as assessed in one of the central amlsg reference laboratories.
boolean
C0023467 (UMLS CUI [1])
age
Item
age ≥ 18; there is no upper age limit.
boolean
C0001779 (UMLS CUI [1])
chemotherapy
Item
no prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the diag-nostic screening phase.
boolean
C0392920 (UMLS CUI [1])
pregnancy, lactation and contraception
Item
non-pregnant and non-nursing. due to the unknown teratogenic potential of dasatinib in humans, pregnant or nursing patients may not be enrolled. women of childbearing poten-tial (wocbp) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 miu/ml within 72 hours prior to registration. women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (e.g., iud, hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (e.g., latex condom, diaphragm, or cervical cap) - at the same time, at least four weeks before she begins dasatinib therapy. "women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
contraception
Item
men must agree not to father a child and must use a latex condom during any sexual con-tact with women of childbearing potential while taking dasatinib and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy.
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
who performance status
Item
performance status who >2
boolean
C1298650 (UMLS CUI [1])
pulmonary edema and/or pleural/pericardial effusion
Item
pulmonary edema and/or pleural/pericardial effusion within 14 days of day 1. if edema/effusion resolves to ctc grade ≤ 1, patients can be treated with dasatinib.
boolean
C0034063 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
ejection fraction
Item
patients with ejection fraction < 50% by echocardiography within 14 days of day 1
boolean
C0232174 (UMLS CUI [1])
organ insufficiency
Item
organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, ast or ap >2.5x upper normal serum level; heart failure nyha iii/iv; severe obstructive or restrictive ventilation disorder)
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0002594 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
infection
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
neurological or psychiatric disorder interfering with ability of giving an informed consent
Item
severe neurological or psychiatric disorder interfering with ability of giving an informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
HIV
Item
known positive for hiv
boolean
C0019682 (UMLS CUI [1])
bleeding disorder
Item
bleeding disorder independent of leukemia
boolean
C0005779 (UMLS CUI [1])
no consent for registration, storage and processing of the individual disease-characteristics and course
Item
no consent for registration, storage and processing of the individual disease-characteristics and course
boolean
C1511481 (UMLS CUI [1])
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