ID

41100

Beschreibung

Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01893320

Link

https://clinicaltrials.gov/show/NCT01893320

Stichworte

Versionen (1)
  1. 24.06.20 24.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

24. Juni 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Leukemia NCT01893320

Englisch

Eligibility Leukemia NCT01893320

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01893320
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. previously untreated aml (>/= 20% blasts). patients with high-risk mds (defined as having >/= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (cmml) (having >/= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (pi). prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed. patients may have received one dose of cytarabine (up to 2 g/m2) administered at presentation for control of hyperleucocytosis. for patients with prior mds or cmml who transformed to aml, therapy received for mds is not considered as prior therapy for aml.
Beschreibung

AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME | Blasts Percentage Bone Marrow | Leukemia, Myelomonocytic, Chronic | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Hematopoietic Cell Growth Factors | Cytarabine Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0368761
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C3463824
UMLS CUI [4,1]
C0368761
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0005953
UMLS CUI [5]
C0023480
UMLS CUI [6]
C0020402
UMLS CUI [7]
C1531518
UMLS CUI [8]
C2985566
UMLS CUI [9]
C4086297
UMLS CUI [10]
C3537035
UMLS CUI [11]
C0079490
UMLS CUI [12,1]
C0010711
UMLS CUI [12,2]
C0178602
2. age >/= 60 years and not candidates for conventional cytotoxic chemotherapy or refuse it; or patients below the age of 60 years who are considered unfit and/or unable to tolerate standard chemotherapy at the discretion of the treating physician or the principal investigator. "
Beschreibung

Age | Patients Inappropriate Cytotoxic Chemotherapy | Cytotoxic Chemotherapy Refused | Patients unfit Chemotherapy | Chemotherapy Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0677881
UMLS CUI [3,1]
C0677881
UMLS CUI [3,2]
C1705116
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0850765
UMLS CUI [4,3]
C0392920
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1514756
UMLS CUI [5,3]
C1299582
3. eastern cooperative oncology group performance status </= 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate hepatic (serum total bilirubin </= 1.5 x upper limit normal (uln), alanine aminotransferase and/or aspartate transaminase </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
Beschreibung

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
5. left ventricular ejection fraction (lvef) at least 40% by multiple gated acquisition (muga) scan or echocardiogram (echo)
Beschreibung

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
6. patients must be willing and able to review, understand, and provide written consent before starting therapy.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
7. females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment. women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test. if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol. women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment. males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment.
Beschreibung

Female Sterilization | Infertility | Postmenopausal state | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Male sterilization | Gender Infertility | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0021359
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430061
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430057
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0700589
UMLS CUI [7]
C0024559
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0021359
UMLS CUI [9,1]
C0079399
UMLS CUI [9,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. new york heart association class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or pi, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or pi, or uncontrolled congestive heart failure in the opinion of the treating physician or pi.
Beschreibung

Heart Disease New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Antihypertensive Agents | Diabetic - poor control | Congestive heart failure Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0022116
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0018787
UMLS CUI [3,3]
C0205318
UMLS CUI [4]
C0002962
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0332121
UMLS CUI [6]
C1868885
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
UMLS CUI [9,1]
C0205269
UMLS CUI [9,2]
C0003364
UMLS CUI [10]
C0421258
UMLS CUI [11,1]
C0018802
UMLS CUI [11,2]
C0205318
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
3. active and uncontrolled disease/infection as judged by the treating physician
Beschreibung

Disease Uncontrolled | Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
4. pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. known human immunodeficiency virus seropositivity
Beschreibung

HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
6. any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
Beschreibung

Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Social Condition Interferes with Protocol Compliance | Other medical condition At risk Patient safety | Mental condition At risk Patient safety | Social Condition At risk Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0037403
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C1444641
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C1444641
UMLS CUI [8,3]
C1113679
UMLS CUI [9,1]
C0037403
UMLS CUI [9,2]
C1444641
UMLS CUI [9,3]
C1113679
7. acute promyelocytic leukemia (apl).
Beschreibung

Acute Promyelocytic Leukemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0023487
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Ähnliche Modelle

Eligibility Leukemia NCT01893320

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01893320
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
AML Untreated | Blasts Percentage | High risk MYELODYSPLASTIC SYNDROME | Blasts Percentage Bone Marrow | Leukemia, Myelomonocytic, Chronic | hydroxyurea | Biological treatment | Targeted Therapy | FLT3 Inhibitor | kinase inhibitor | Hematopoietic Cell Growth Factors | Cytarabine Dose
Item
1. previously untreated aml (>/= 20% blasts). patients with high-risk mds (defined as having >/= 10% blasts in the bone marrow) or patients with chronic myelomonocytic leukemia (cmml) (having >/= 10% blasts in the bone marrow) may also be eligible after discussion with principal investigator (pi). prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed. patients may have received one dose of cytarabine (up to 2 g/m2) administered at presentation for control of hyperleucocytosis. for patients with prior mds or cmml who transformed to aml, therapy received for mds is not considered as prior therapy for aml.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0368761 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C4319571 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C0368761 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0005953 (UMLS CUI [4,3])
C0023480 (UMLS CUI [5])
C0020402 (UMLS CUI [6])
C1531518 (UMLS CUI [7])
C2985566 (UMLS CUI [8])
C4086297 (UMLS CUI [9])
C3537035 (UMLS CUI [10])
C0079490 (UMLS CUI [11])
C0010711 (UMLS CUI [12,1])
C0178602 (UMLS CUI [12,2])
Age | Patients Inappropriate Cytotoxic Chemotherapy | Cytotoxic Chemotherapy Refused | Patients unfit Chemotherapy | Chemotherapy Receive Unable
Item
2. age >/= 60 years and not candidates for conventional cytotoxic chemotherapy or refuse it; or patients below the age of 60 years who are considered unfit and/or unable to tolerate standard chemotherapy at the discretion of the treating physician or the principal investigator. "
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0677881 (UMLS CUI [2,3])
C0677881 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0850765 (UMLS CUI [4,2])
C0392920 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5,1])
C1514756 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
ECOG performance status
Item
3. eastern cooperative oncology group performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
4. adequate hepatic (serum total bilirubin </= 1.5 x upper limit normal (uln), alanine aminotransferase and/or aspartate transaminase </= 2.5 x uln) and renal function (creatinine </= 2.0 mg/dl).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
5. left ventricular ejection fraction (lvef) at least 40% by multiple gated acquisition (muga) scan or echocardiogram (echo)
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Informed Consent
Item
6. patients must be willing and able to review, understand, and provide written consent before starting therapy.
boolean
C0021430 (UMLS CUI [1])
Female Sterilization | Infertility | Postmenopausal state | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods | Male sterilization | Gender Infertility | Gender Contraceptive methods
Item
7. females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment. women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test. if either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol. women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment. males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment.
boolean
C0015787 (UMLS CUI [1])
C0021359 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0430057 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0024559 (UMLS CUI [7])
C0079399 (UMLS CUI [8,1])
C0021359 (UMLS CUI [8,2])
C0079399 (UMLS CUI [9,1])
C0700589 (UMLS CUI [9,2])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification | Ischemia | Condition cardiac Uncontrolled | Angina Pectoris | Cardiac Arrhythmia Treatment required for | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Antihypertensive Agents | Diabetic - poor control | Congestive heart failure Uncontrolled
Item
1. new york heart association class iii or iv heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or pi, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or pi, or uncontrolled congestive heart failure in the opinion of the treating physician or pi.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0022116 (UMLS CUI [2])
C0348080 (UMLS CUI [3,1])
C0018787 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0332121 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
C0205269 (UMLS CUI [9,1])
C0003364 (UMLS CUI [9,2])
C0421258 (UMLS CUI [10])
C0018802 (UMLS CUI [11,1])
C0205318 (UMLS CUI [11,2])
Myocardial Infarction
Item
2. myocardial infarction in the previous 12 weeks (from the start of treatment).
boolean
C0027051 (UMLS CUI [1])
Disease Uncontrolled | Communicable Disease Uncontrolled
Item
3. active and uncontrolled disease/infection as judged by the treating physician
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
4. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
5. known human immunodeficiency virus seropositivity
boolean
C0019699 (UMLS CUI [1])
Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Social Condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Protocol Compliance | Mental condition Interferes with Protocol Compliance | Social Condition Interferes with Protocol Compliance | Other medical condition At risk Patient safety | Mental condition At risk Patient safety | Social Condition At risk Patient safety
Item
6. any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0037403 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0037403 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C1444641 (UMLS CUI [8,2])
C1113679 (UMLS CUI [8,3])
C0037403 (UMLS CUI [9,1])
C1444641 (UMLS CUI [9,2])
C1113679 (UMLS CUI [9,3])
Acute Promyelocytic Leukemia
Item
7. acute promyelocytic leukemia (apl).
boolean
C0023487 (UMLS CUI [1])
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