ID

41085

Description

Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT01515527

Lien

https://clinicaltrials.gov/show/NCT01515527

Mots-clés

Versions (1)
  1. 22/06/2020 22/06/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

22 juin 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Leukemia NCT01515527

Anglais

Eligibility Leukemia NCT01515527

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01515527
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with previously untreated aml or high risk mds (>/= 10 % blasts or ipss >/= intermediate-2). prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, atra, or an isolated dose of cytarabine up to 2g is allowed. patients with history of mds transformed to aml are eligible regardless of their prior therapy for mds provided this will be their first induction therapy for aml.
Description

AML Untreated | High risk MDS | Blasts Percentage | IPSS | hydroxyurea | Hematopoietic Cell Growth Factors | Azacitidine | ATRA | Cytarabine Dose

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C3463824
UMLS CUI [3,1]
C0368761
UMLS CUI [3,2]
C0439165
UMLS CUI [4]
C2827405
UMLS CUI [5]
C0020402
UMLS CUI [6]
C0079490
UMLS CUI [7]
C0004475
UMLS CUI [8]
C0040845
UMLS CUI [9,1]
C0010711
UMLS CUI [9,2]
C0178602
2. age >/= 60 years. patients aged < 60 years who are unsuitable for standard induction therapy may be eligible after discussion with pi
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. adequate organ function as defined below: liver function (bilirubin </= 2mg/dl, ast and/or alt </=3 x uln) kidney function (creatinine </= 1.5 x uln ).
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0232741
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0232804
UMLS CUI [7]
C0201976
4. ecog performance status of </= 2.
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
5. a negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
Description

Childbearing Potential Urine pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
6. patient must have the ability to understand the requirements of the study and signed informed consent. a signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
Description

Informed Consent | Informed Consent Patient Representative

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
7. prior therapy with decitabine will be allowed unless the patient experienced progression to aml while being treated with decitabine.
Description

Decitabine allowed | Exception Disease Progression AML

Type de données

boolean

Alias
UMLS CUI [1,1]
C0049065
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0242656
UMLS CUI [2,3]
C0023467
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

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

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
3. patient with documented hypersensitivity to any of the components of the chemotherapy program.
Description

Hypersensitivity Component Chemotherapy Regimen

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0392920
4. men and women of childbearing potential who do not practice contraception. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Description

Females & males of reproductive potential Contraceptive methods Absent | Childbearing Potential Contraceptive methods Willing | Gender Contraceptive methods Willing

Type de données

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0600109
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0600109
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Similar models

Eligibility Leukemia NCT01515527

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01515527
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
AML Untreated | High risk MDS | Blasts Percentage | IPSS | hydroxyurea | Hematopoietic Cell Growth Factors | Azacitidine | ATRA | Cytarabine Dose
Item
1. patients with previously untreated aml or high risk mds (>/= 10 % blasts or ipss >/= intermediate-2). prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, atra, or an isolated dose of cytarabine up to 2g is allowed. patients with history of mds transformed to aml are eligible regardless of their prior therapy for mds provided this will be their first induction therapy for aml.
boolean
C0023467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C4319571 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
C0368761 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C2827405 (UMLS CUI [4])
C0020402 (UMLS CUI [5])
C0079490 (UMLS CUI [6])
C0004475 (UMLS CUI [7])
C0040845 (UMLS CUI [8])
C0010711 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
Age
Item
2. age >/= 60 years. patients aged < 60 years who are unsuitable for standard induction therapy may be eligible after discussion with pi
boolean
C0001779 (UMLS CUI [1])
Organ function | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
3. adequate organ function as defined below: liver function (bilirubin </= 2mg/dl, ast and/or alt </=3 x uln) kidney function (creatinine </= 1.5 x uln ).
boolean
C0678852 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0232804 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
ECOG performance status
Item
4. ecog performance status of </= 2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
5. a negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Informed Consent | Informed Consent Patient Representative
Item
6. patient must have the ability to understand the requirements of the study and signed informed consent. a signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Decitabine allowed | Exception Disease Progression AML
Item
7. prior therapy with decitabine will be allowed unless the patient experienced progression to aml while being treated with decitabine.
boolean
C0049065 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
C0023467 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
2. uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Hypersensitivity Component Chemotherapy Regimen
Item
3. patient with documented hypersensitivity to any of the components of the chemotherapy program.
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Females & males of reproductive potential Contraceptive methods Absent | Childbearing Potential Contraceptive methods Willing | Gender Contraceptive methods Willing
Item
4. men and women of childbearing potential who do not practice contraception. women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
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