ID

13562

Description

Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01238211

Link

https://clinicaltrials.gov/show/NCT01238211

Keywords

Versions (1)
  1. 2/16/16 2/16/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 16, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01238211

English

Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01238211

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documentation of disease as assessed by the alliance reference laboratory at the ohio state university per cancer and leukemia group b (calgb) 20202, molecular diagnosis of core-binding factor (cbf) acute myeloid leukemia (aml) by reverse transcriptase polymerase chain reaction (rt-pcr) positive for runt-related transcription factor 1(runx1)-runt-related transcription factor 1; translocated to 1 (runx1t1) fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or core binding factor β-chain (cbfb)-myosin heavy chain 11 gene (myh11) fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of cbf aml based on the world health organization [who] classification)
Description

documentation of disease as assessed by the alliance reference laboratory at the ohio state university per cancer and leukemia group b (calgb) 20202, molecular diagnosis of core-binding factor (cbf) acute myeloid leukemia (aml) by reverse transcriptase polymerase chain reaction (rt-pcr) positive for runt-related transcription factor 1(runx1)-runt-related transcription factor 1; translocated to 1 (runx1t1) fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or core binding factor β-chain (cbfb)-myosin heavy chain 11 gene (myh11) fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of cbf aml based on the world health organization [who] classification)

Data type

boolean

Alias
UMLS CUI [1]
C3839741
UMLS CUI [2]
C1335654
no prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea, cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only), growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted agents
Description

no prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea, cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only), growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted agents

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0023416
UMLS CUI [2,2]
C0013956
UMLS CUI [3,1]
C0020402
UMLS CUI [3,2]
C0013956
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0282548
UMLS CUI [5]
C0018284
UMLS CUI [6]
C0199974
aml patients with a history of antecedent myelodysplasia (mds) remain eligible for treatment on this trial
Description

MDS

Data type

boolean

Alias
UMLS CUI [1]
C3463824
patients who have developed therapy related myeloid neoplasm (t-mn) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible
Description

patients who have developed therapy related myeloid neoplasm (t-mn) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible

Data type

boolean

Alias
UMLS CUI [1,1]
C2939461
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C2924519
left ventricular ejection fraction >= lower limit of institutional normal by multigated acquisition (muga) or echocardiogram (echo) scan
Description

LVEF

Data type

boolean

Alias
UMLS CUI [1]
C0428772
patients must not have had myocardial infarction within 6 months of registration
Description

myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
patients must not have had ventricular tachyarrhythmia within 6 months of registration
Description

ventricular tachyarrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0042514
patients must have no major conduction abnormality (unless a cardiac pacemaker is present)
Description

conduction abnormality

Data type

boolean

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0030163
bilirubin must not be < 2.5 times upper limit of normal
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (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., intrauterine device [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, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "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
Description

patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (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., intrauterine device [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, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "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

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0700589
patients with congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation (defined as a qtc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded
Description

patients with congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation (defined as a qtc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded

Data type

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C0151878
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Similar models

Eligibility Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome NCT01238211

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
cbf aml
Item
documentation of disease as assessed by the alliance reference laboratory at the ohio state university per cancer and leukemia group b (calgb) 20202, molecular diagnosis of core-binding factor (cbf) acute myeloid leukemia (aml) by reverse transcriptase polymerase chain reaction (rt-pcr) positive for runt-related transcription factor 1(runx1)-runt-related transcription factor 1; translocated to 1 (runx1t1) fusion transcript resulting from t(8;21)(q22;q22) (or a variant form) or core binding factor β-chain (cbfb)-myosin heavy chain 11 gene (myh11) fusion transcript resulting from inv(16)(p13.1q22) or t(16;16)(p13.1;q22) (any % bone marrow or blood blasts render the diagnosis of cbf aml based on the world health organization [who] classification)
boolean
C3839741 (UMLS CUI [1])
C1335654 (UMLS CUI [2])
no prior chemotherapy
Item
no prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis emergency treatment for hyperleukocytosis with hydroxyurea, cranial radiotherapy (rt) for central nervous system (cns) leukostasis (one dose only), growth factor and/or cytokine support and/or non-cytotoxic molecular-targeted agents
boolean
C1514457 (UMLS CUI [1])
C0023416 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0020402 (UMLS CUI [3,1])
C0013956 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0282548 (UMLS CUI [4,2])
C0018284 (UMLS CUI [5])
C0199974 (UMLS CUI [6])
MDS
Item
aml patients with a history of antecedent myelodysplasia (mds) remain eligible for treatment on this trial
boolean
C3463824 (UMLS CUI [1])
therapy related myeloid neoplasm
Item
patients who have developed therapy related myeloid neoplasm (t-mn) after prior radiation therapy or chemotherapy for another cancer or disorder are eligible
boolean
C2939461 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2924519 (UMLS CUI [1,3])
LVEF
Item
left ventricular ejection fraction >= lower limit of institutional normal by multigated acquisition (muga) or echocardiogram (echo) scan
boolean
C0428772 (UMLS CUI [1])
myocardial infarction
Item
patients must not have had myocardial infarction within 6 months of registration
boolean
C0027051 (UMLS CUI [1])
ventricular tachyarrhythmia
Item
patients must not have had ventricular tachyarrhythmia within 6 months of registration
boolean
C0042514 (UMLS CUI [1])
conduction abnormality
Item
patients must have no major conduction abnormality (unless a cardiac pacemaker is present)
boolean
C0232219 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
bilirubin
Item
bilirubin must not be < 2.5 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
non-pregnant and non-nursing
Item
patients must be non-pregnant and non-nursing; pregnant or nursing patients may not be enrolled; women of childbearing potential (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., intrauterine device [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, before she begins dasatinib therapy, during treatment and at least 12 weeks after treatment is complete; "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
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation
Item
patients with congenital long qt syndrome or non-congenital corrected qt (qtc) prolongation (defined as a qtc interval consistently equal to or greater than 480 msecs) that cannot be corrected by infusion of electrolytes and/or discontinuation of other medications prior to start of treatment are excluded
boolean
C0023976 (UMLS CUI [1])
C0151878 (UMLS CUI [2])
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