ID

41103

Description

4-Arm Phase II Study of SGI-110 in Elderly Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT02096055

Link

https://clinicaltrials.gov/show/NCT02096055

Keywords

Versions (1)
  1. 6/24/20 6/24/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 24, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02096055

English

Eligibility Leukemia NCT02096055

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02096055
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. previously untreated aml patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed.
Description

AML Untreated | Exception Prior Therapy | Exception Hydroxyurea | Exception Decitabine | Exception Hematopoietic Growth Factors | Exception Biological treatment | Exception Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1514463
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020402
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0049065
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0079490
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1531518
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C2985566
2. age >/= 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog performance status </= 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. sign a written informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
5. adequate liver function (total bilirubin </= 2mg/dl, sgpt or sgot </= x 4 uln) and renal function creatinine clearance of >/= 50 ml/min (estimated by the cockcroft-gault [c-g] formula).
Description

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

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]
C2711451
6. male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment.
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
7. baseline lvef >/= 40%.
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with >/= nyha grade 3 heart disease as assessed by history and/or physical examination.
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
2. patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
Description

Hypomethylation Therapy Course Quantity | azacitidine | decitabine

Data type

boolean

Alias
UMLS CUI [1,1]
C4054751
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0004475
UMLS CUI [3]
C0049065
3. have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
Description

Comorbidity Severe | Organ dysfunction Serious | Cardiac dysfunction | Heart Disease | Abnormal renal function | Kidney Disease | Liver Dysfunction | Liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0349410
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C3277906
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0151746
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0086565
UMLS CUI [8]
C0023895
4. patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Description

Systemic mycosis Uncontrolled | Systemic bacterial infection Uncontrolled | Systemic viral infection Uncontrolled | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0553576
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C4285778
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C4285789
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
5. pregnant or lactating patients.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
Description

Comorbidity At risk Patient safety | Mental disorders At risk Patient safety | Comorbidity At risk Compliance | Mental disorder At risk Compliance | Comorbidity Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Comorbidity Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Comorbidity Interferes with Follow-up | Mental disorder Interferes with Follow-up | Comorbidity Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1321605
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C1321605
UMLS CUI [5,1]
C0009488
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0021430
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0021430
UMLS CUI [7,1]
C0009488
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C2348568
UMLS CUI [8,1]
C0004936
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2348568
UMLS CUI [9,1]
C0009488
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C3274571
UMLS CUI [10,1]
C0004936
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C3274571
UMLS CUI [11,1]
C0009488
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0004936
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
7. any concurrent malignancy (with the exception of exclusion # 8)
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
8. exceptions to # 7: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Description

Exception | Skin carcinoma Treated | Carcinoma in Situ Treated | Cervical Intraepithelial Neoplasia Treated | Prostate carcinoma Prostate specific antigen measurement | Recurrence Absent | Progressive Disease Absent | Hormone Therapy Initiation | Radical prostatectomy Performed

Data type

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0007099
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0206708
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0600139
UMLS CUI [5,2]
C0201544
UMLS CUI [6,1]
C0034897
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C1335499
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0279025
UMLS CUI [8,2]
C1704686
UMLS CUI [9,1]
C0194810
UMLS CUI [9,2]
C0884358
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Similar models

Eligibility Leukemia NCT02096055

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02096055
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML Untreated | Exception Prior Therapy | Exception Hydroxyurea | Exception Decitabine | Exception Hematopoietic Growth Factors | Exception Biological treatment | Exception Targeted Therapy
Item
1. previously untreated aml patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0049065 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0079490 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1531518 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C2985566 (UMLS CUI [7,2])
Age
Item
2. age >/= 70 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status </= 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
4. sign a written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. adequate liver function (total bilirubin </= 2mg/dl, sgpt or sgot </= x 4 uln) and renal function creatinine clearance of >/= 50 ml/min (estimated by the cockcroft-gault [c-g] formula).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
Gender Contraceptive methods
Item
6. male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
7. baseline lvef >/= 40%.
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease New York Heart Association Classification
Item
1. patients with >/= nyha grade 3 heart disease as assessed by history and/or physical examination.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Hypomethylation Therapy Course Quantity | azacitidine | decitabine
Item
2. patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
boolean
C4054751 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004475 (UMLS CUI [2])
C0049065 (UMLS CUI [3])
Comorbidity Severe | Organ dysfunction Serious | Cardiac dysfunction | Heart Disease | Abnormal renal function | Kidney Disease | Liver Dysfunction | Liver disease
Item
3. have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0349410 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3277906 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0086565 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
Systemic mycosis Uncontrolled | Systemic bacterial infection Uncontrolled | Systemic viral infection Uncontrolled | Communicable Disease Uncontrolled
Item
4. patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
boolean
C0553576 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C4285778 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C4285789 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
5. pregnant or lactating patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity At risk Patient safety | Mental disorders At risk Patient safety | Comorbidity At risk Compliance | Mental disorder At risk Compliance | Comorbidity Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Comorbidity Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Comorbidity Interferes with Follow-up | Mental disorder Interferes with Follow-up | Comorbidity Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results
Item
6. any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1321605 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C0009488 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C0009488 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C2348568 (UMLS CUI [7,3])
C0004936 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0009488 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C3274571 (UMLS CUI [9,3])
C0004936 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C3274571 (UMLS CUI [10,3])
C0009488 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0004936 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Cancer Other
Item
7. any concurrent malignancy (with the exception of exclusion # 8)
boolean
C1707251 (UMLS CUI [1])
Exception | Skin carcinoma Treated | Carcinoma in Situ Treated | Cervical Intraepithelial Neoplasia Treated | Prostate carcinoma Prostate specific antigen measurement | Recurrence Absent | Progressive Disease Absent | Hormone Therapy Initiation | Radical prostatectomy Performed
Item
8. exceptions to # 7: a) patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (psa) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
boolean
C1705847 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007099 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0206708 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0600139 (UMLS CUI [5,1])
C0201544 (UMLS CUI [5,2])
C0034897 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C1335499 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0279025 (UMLS CUI [8,1])
C1704686 (UMLS CUI [8,2])
C0194810 (UMLS CUI [9,1])
C0884358 (UMLS CUI [9,2])
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