ID

41108

Description

A Leukemia SPORE Phase II Clinical Trial Comparing Decitabine Versus Decitabine/Carboplatin and Decitabine/Arsenic for the Treatment of Relapsed, Refractory, and Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT02188706

Link

https://clinicaltrials.gov/show/NCT02188706

Keywords

Versions (1)
  1. 6/25/20 6/25/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 25, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT02188706

English

Eligibility Leukemia NCT02188706

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02188706
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with aml, relapsed or refractory to standard therapy or elderly patients with aml (age 65 or over). patients who have aml and are younger than age 65 but considered unfit for conventional chemotherapy are eligible. patients with de novo or treated mds or cmml int-1 or above are eligible. patients may have had prior exposure to azacitidine but no more than one cycle of decitabine. patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxicities of that therapy; a caveat to this is in the case of rapidly progressive disease. hydroxyurea is permitted for control of elevated wbc prior to treatment and can be continued for the first 4 weeks of therapy. erythropoiesis stimulating agents (esas) and gcsf are allowed before therapy. esas, gcsf or other growth factors are permitted on therapy.
Description

Recurrent Acute Myeloid Leukemia | AML Unresponsive to Standard therapy | AML Elderly | Age | Patient unfit for Chemotherapy | MYELODYSPLASTIC SYNDROME de novo IPSS | MYELODYSPLASTIC SYNDROME Treated IPSS | CMML IPSS | Exposure to azacitidine | decitabine | Toxicity Due to Therapy | Patient recovered | hydroxyurea | Erythropoiesis-stimulating Agent | Granulocyte Colony-Stimulating Factor | Growth Factor

Data type

boolean

Alias
UMLS CUI [1]
C1142169
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C2936643
UMLS CUI [3,1]
C0023467
UMLS CUI [3,2]
C0001792
UMLS CUI [4]
C0001779
UMLS CUI [5,1]
C3839996
UMLS CUI [5,2]
C0392920
UMLS CUI [6,1]
C3463824
UMLS CUI [6,2]
C1515568
UMLS CUI [6,3]
C2827405
UMLS CUI [7,1]
C3463824
UMLS CUI [7,2]
C1522326
UMLS CUI [7,3]
C2827405
UMLS CUI [8,1]
C0023480
UMLS CUI [8,2]
C2827405
UMLS CUI [9,1]
C0332157
UMLS CUI [9,2]
C0004475
UMLS CUI [10]
C0049065
UMLS CUI [11,1]
C0600688
UMLS CUI [11,2]
C0678226
UMLS CUI [11,3]
C0087111
UMLS CUI [12]
C1115804
UMLS CUI [13]
C0020402
UMLS CUI [14]
C2917382
UMLS CUI [15]
C0079459
UMLS CUI [16]
C0018284
2. performance 0-2 (ecog).
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded).
Description

Cardiac function Echocardiography second | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0013516
UMLS CUI [1,3]
C0205436
UMLS CUI [2]
C1275491
4. pre-treatment ekg
Description

ECG pre treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C2709094
5. adequate end organ function with creatinine </= 2mg/dl and total bilirubin </= 2mg/dl, ast and alt </= or = 2.5 x institutional uln.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0201976
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
6. absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving of informed consent.
Description

Comorbidity Significant;Absent | Absence Heart failure Uncontrolled | Unstable Angina Absent | Cardiac Arrhythmia Absent | Mental disorders Absent | Mental disorders Exclude Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0018801
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0002965
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0021430
7. signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nursing and pregnant females. patients of childbearing potential should practice effective methods of contraception. should a woman become preg-nant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
2. current uncontrolled infections.
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
3. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0742758
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C0439801
UMLS CUI [5,3]
C0525058
4. chronic kidney disease > stage 3.
Description

Chronic Kidney Disease Stage

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C2074731
5. hiv infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Leukemia NCT02188706

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02188706
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Acute Myeloid Leukemia | AML Unresponsive to Standard therapy | AML Elderly | Age | Patient unfit for Chemotherapy | MYELODYSPLASTIC SYNDROME de novo IPSS | MYELODYSPLASTIC SYNDROME Treated IPSS | CMML IPSS | Exposure to azacitidine | decitabine | Toxicity Due to Therapy | Patient recovered | hydroxyurea | Erythropoiesis-stimulating Agent | Granulocyte Colony-Stimulating Factor | Growth Factor
Item
1. patients with aml, relapsed or refractory to standard therapy or elderly patients with aml (age 65 or over). patients who have aml and are younger than age 65 but considered unfit for conventional chemotherapy are eligible. patients with de novo or treated mds or cmml int-1 or above are eligible. patients may have had prior exposure to azacitidine but no more than one cycle of decitabine. patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxicities of that therapy; a caveat to this is in the case of rapidly progressive disease. hydroxyurea is permitted for control of elevated wbc prior to treatment and can be continued for the first 4 weeks of therapy. erythropoiesis stimulating agents (esas) and gcsf are allowed before therapy. esas, gcsf or other growth factors are permitted on therapy.
boolean
C1142169 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [2,3])
C0023467 (UMLS CUI [3,1])
C0001792 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C3839996 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C3463824 (UMLS CUI [6,1])
C1515568 (UMLS CUI [6,2])
C2827405 (UMLS CUI [6,3])
C3463824 (UMLS CUI [7,1])
C1522326 (UMLS CUI [7,2])
C2827405 (UMLS CUI [7,3])
C0023480 (UMLS CUI [8,1])
C2827405 (UMLS CUI [8,2])
C0332157 (UMLS CUI [9,1])
C0004475 (UMLS CUI [9,2])
C0049065 (UMLS CUI [10])
C0600688 (UMLS CUI [11,1])
C0678226 (UMLS CUI [11,2])
C0087111 (UMLS CUI [11,3])
C1115804 (UMLS CUI [12])
C0020402 (UMLS CUI [13])
C2917382 (UMLS CUI [14])
C0079459 (UMLS CUI [15])
C0018284 (UMLS CUI [16])
ECOG performance status
Item
2. performance 0-2 (ecog).
boolean
C1520224 (UMLS CUI [1])
Cardiac function Echocardiography second | New York Heart Association Classification
Item
3. adequate cardiac functions assessed by 2d echo (nyha cardiac iii-iv excluded).
boolean
C0232164 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C1275491 (UMLS CUI [2])
ECG pre treatment
Item
4. pre-treatment ekg
boolean
C0013798 (UMLS CUI [1,1])
C2709094 (UMLS CUI [1,2])
Organ function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. adequate end organ function with creatinine </= 2mg/dl and total bilirubin </= 2mg/dl, ast and alt </= or = 2.5 x institutional uln.
boolean
C0678852 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
Comorbidity Significant;Absent | Absence Heart failure Uncontrolled | Unstable Angina Absent | Cardiac Arrhythmia Absent | Mental disorders Absent | Mental disorders Exclude Informed Consent
Item
6. absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving of informed consent.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0002965 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0004936 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
Informed Consent
Item
7. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods
Item
1. nursing and pregnant females. patients of childbearing potential should practice effective methods of contraception. should a woman become preg-nant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Communicable Disease Uncontrolled
Item
2. current uncontrolled infections.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
3. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
Chronic Kidney Disease Stage
Item
4. chronic kidney disease > stage 3.
boolean
C1561643 (UMLS CUI [1,1])
C2074731 (UMLS CUI [1,2])
HIV Infection
Item
5. hiv infection.
boolean
C0019693 (UMLS CUI [1])
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