ID

41092

Description

E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes; ODM derived from: https://clinicaltrials.gov/show/NCT01692197

Link

https://clinicaltrials.gov/show/NCT01692197

Keywords

Versions (1)
  1. 6/23/20 6/23/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 23, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT01692197

English

Eligibility Leukemia NCT01692197

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01692197
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (aml) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (hrmds) (int-2 high risk by ipss or >10% blasts in marrow).
Description

Acute myeloid leukaemia recurrent | Refractory Acute Myeloid Leukemia | Exception Acute Promyelocytic Leukemia | High Risk Myelodysplastic Syndrome IPSS | Blasts Percentage Bone Marrow

Data type

boolean

Alias
UMLS CUI [1]
C1142169
UMLS CUI [2]
C4528668
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023487
UMLS CUI [4,1]
C4528176
UMLS CUI [4,2]
C2827405
UMLS CUI [5,1]
C0368761
UMLS CUI [5,2]
C0439165
UMLS CUI [5,3]
C0005953
2. patients must be 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. patients must have a performance status of 0-2 (zubrod scale).
Description

Zubrod Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C3714786
4. patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dl and/or creatinine clearance > 40 ml/min). patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (pi) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
5. patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; sgot or sgpt less than or equal to 3x the uln for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). patients with hepatic dysfunction (sgot/sgpt up to less than or equal to 5 x uln) due to organ infiltration by disease may be eligible after discussion with the pi, and appropriate dose adjustments will be considered.
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Due to Leukemia | Exception Due to Hemolytic disorder | Exception Due to Bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0023418
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C1263988
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0005437
6. patients must have normal cardiac ejection fraction
Description

Normal cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C3661818
7. qtc interval </= 480 msecs.
Description

QTc interval

Data type

boolean

Alias
UMLS CUI [1]
C0489625
8. patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
9. female patients must not be pregnant or lactating. female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
Description

Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients must not have untreated or uncontrolled life-threatening infection.
Description

Life-threatening infection Untreated | Life-threatening infection Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C1859430
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1859430
UMLS CUI [2,2]
C0205318
2. patients must not have received chemotherapy and/or radiation therapy within 2 weeks. hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 cycle 1. maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
Description

Chemotherapy | Therapeutic radiology procedure | Hydroxyurea allowed Rapid disease progression | Hydroxyurea Dose U/day | Hydroxyurea To be stopped

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0020402
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C1834700
UMLS CUI [4,1]
C0020402
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0456683
UMLS CUI [5,1]
C0020402
UMLS CUI [5,2]
C1272691
3. any other medical condition, including mental illness or substance abuse, deemed by the pi to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
Description

Other medical condition Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance | Substance Use Disorder Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0038586
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C3843040
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]
C0038586
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2348568
UMLS CUI [10,1]
C3843040
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0459471
UMLS CUI [10,4]
C0683954
UMLS CUI [11,1]
C0004936
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0459471
UMLS CUI [11,4]
C0683954
UMLS CUI [12,1]
C0038586
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0459471
UMLS CUI [12,4]
C0683954
4. patients must not have received an investigational anti-cancer drug within two weeks of e7070 administration.
Description

Antineoplastic Agent Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1517586
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Similar models

Eligibility Leukemia NCT01692197

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01692197
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute myeloid leukaemia recurrent | Refractory Acute Myeloid Leukemia | Exception Acute Promyelocytic Leukemia | High Risk Myelodysplastic Syndrome IPSS | Blasts Percentage Bone Marrow
Item
1. all patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (aml) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (hrmds) (int-2 high risk by ipss or >10% blasts in marrow).
boolean
C1142169 (UMLS CUI [1])
C4528668 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0023487 (UMLS CUI [3,2])
C4528176 (UMLS CUI [4,1])
C2827405 (UMLS CUI [4,2])
C0368761 (UMLS CUI [5,1])
C0439165 (UMLS CUI [5,2])
C0005953 (UMLS CUI [5,3])
Age
Item
2. patients must be 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
3. patients must have a performance status of 0-2 (zubrod scale).
boolean
C3714786 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
4. patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dl and/or creatinine clearance > 40 ml/min). patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the principal investigator (pi) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Exception Due to Leukemia | Exception Due to Hemolytic disorder | Exception Due to Bilirubin
Item
5. patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; sgot or sgpt less than or equal to 3x the uln for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). patients with hepatic dysfunction (sgot/sgpt up to less than or equal to 5 x uln) due to organ infiltration by disease may be eligible after discussion with the pi, and appropriate dose adjustments will be considered.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0023418 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C1263988 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0005437 (UMLS CUI [7,3])
Normal cardiac ejection fraction
Item
6. patients must have normal cardiac ejection fraction
boolean
C3661818 (UMLS CUI [1])
QTc interval
Item
7. qtc interval </= 480 msecs.
boolean
C0489625 (UMLS CUI [1])
Informed Consent
Item
8. patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
boolean
C0021430 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
9. female patients must not be pregnant or lactating. female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Life-threatening infection Untreated | Life-threatening infection Uncontrolled
Item
1. patients must not have untreated or uncontrolled life-threatening infection.
boolean
C1859430 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1859430 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Chemotherapy | Therapeutic radiology procedure | Hydroxyurea allowed Rapid disease progression | Hydroxyurea Dose U/day | Hydroxyurea To be stopped
Item
2. patients must not have received chemotherapy and/or radiation therapy within 2 weeks. hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 cycle 1. maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0020402 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C1834700 (UMLS CUI [3,3])
C0020402 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C0020402 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Other medical condition Interferes with Informed Consent | Mental disorder Interferes with Informed Consent | Substance Use Disorder Interferes with Informed Consent | Other medical condition Interferes with Protocol Compliance | Mental disorder Interferes with Protocol Compliance | Substance Use Disorder Interferes with Protocol Compliance | Other medical condition Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status | Substance Use Disorder Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental disorder Interferes with Interpretation Research results | Substance Use Disorder Interferes with Interpretation Research results
Item
3. any other medical condition, including mental illness or substance abuse, deemed by the pi to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0038586 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C3843040 (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])
C0038586 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
C3843040 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0459471 (UMLS CUI [10,3])
C0683954 (UMLS CUI [10,4])
C0004936 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0038586 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0459471 (UMLS CUI [12,3])
C0683954 (UMLS CUI [12,4])
Antineoplastic Agent Investigational
Item
4. patients must not have received an investigational anti-cancer drug within two weeks of e7070 administration.
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
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