ID

41128

Descripción

Randomised Study of Azacitidine Versus Azacitidine in Combination With Vorinostat in Patients With Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes; ODM derived from: https://clinicaltrials.gov/show/NCT01617226

Link

https://clinicaltrials.gov/show/NCT01617226

Palabras clave

Versiones (1)
  1. 27/6/20 27/6/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de junio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT01617226

Inglés

Eligibility Leukemia, Myeloid, Acute NCT01617226

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults with aml (except acute promyelocytic leukaemia (apl)) as defined by the world health organisation (who) classification or patients with high risk mds categorised as int-2 or high risk according to the international prognostic scoring system (ipss) who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities with one of the following disease status:- i) newly diagnosed or
Descripción

Adult | AML WHO tumor classification | Exception Acute Promyelocytic Leukemia | High risk MYELODYSPLASTIC SYNDROME IPSS | Patient Inappropriate Chemotherapy With intensity | Age | Comorbidity | Disease Newly Diagnosed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C1301142
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023487
UMLS CUI [4,1]
C4319571
UMLS CUI [4,2]
C3463824
UMLS CUI [4,3]
C2827405
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C0392920
UMLS CUI [5,4]
C0522510
UMLS CUI [6]
C0001779
UMLS CUI [7]
C0009488
UMLS CUI [8,1]
C0012634
UMLS CUI [8,2]
C1518321
ii) relapsed disease: patients must have achieved a previous morphological cr and show evidence of recurrent disease or
Descripción

Recurrent disease | Morphologic Complete Response Previous

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C4054467
UMLS CUI [2,2]
C0205156
iii) refractory disease: patients who have failed to achieve a morphological cr with previous therapy
Descripción

Refractory Disease | Morphologic Complete Response Failed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2,1]
C4054467
UMLS CUI [2,2]
C0231175
patients are able to receive treatment as out-patient
Descripción

Ability Outpatient Treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0029921
UMLS CUI [1,3]
C0087111
adequate renal and hepatic function as defined in the protocol
Descripción

Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
patients have given written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
ecog performance status less than or equal to 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with greater than class iii nyha cardiac impairment
Descripción

Impairment cardiac New York Heart Association Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221099
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C1275491
blastic transformation of chronic myeloid leukaemia
Descripción

Blast Phase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005699
prior allogeneic/autologous haematopoietic stem cell transplant
Descripción

Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2]
C2193200
pregnant or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
adults of reproductive potential not willing to use appropriate, effective, contraception during the trial and for specified amount of time afterwards
Descripción

Females & males of reproductive potential Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patients who have received prior histone deacetylase inhibitor (hdaci) treatment as anti-tumour therapy. (patients who have received hdaci treatment for other indications e.g valproic acid for epilepsy may enrol after a 30-day washout period)
Descripción

Histone deacetylase inhibitor | Cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512474
UMLS CUI [2]
C0920425
previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 30 days before the start of protocol treatment. (patients receiving anti-tumour therapies to control blood counts may enrol into the trial)
Descripción

Cancer treatment | Investigational New Drugs | Small Molecule Against Neoplasm | Biological agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0027651
UMLS CUI [4]
C0005515
patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine
Descripción

Demethylating Agent | azacitidine | decitabine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4329713
UMLS CUI [2]
C0004475
UMLS CUI [3]
C0049065
patients with contraindications to receiving azacitidine or vorinostat such as hypersensitivity, patients unable to have a subcutaneous injection or swallow oral capsules
Descripción

Medical contraindication azacitidine | Medical contraindication vorinostat | Hypersensitivity azacitidine | Hypersensitivity vorinostat | Subcutaneous Injections Receive Unable | Lacking Able to swallow Capsule

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004475
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0672708
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0004475
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0672708
UMLS CUI [5,1]
C0021499
UMLS CUI [5,2]
C1514756
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C0332268
UMLS CUI [6,2]
C2712086
UMLS CUI [6,3]
C0006935
active symptomatic fungal, bacterial, and/or viral infection including known active hiv or known viral (a, b, or c) hepatitis
Descripción

Mycoses Symptomatic | Bacterial Infections Symptomatic | Virus Diseases Symptomatic | HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0026946
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0004623
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0019159
UMLS CUI [6]
C0019163
UMLS CUI [7]
C0019196
any co-morbidity that could limit compliance with the trial
Descripción

Comorbidity Limiting Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT01617226

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | AML WHO tumor classification | Exception Acute Promyelocytic Leukemia | High risk MYELODYSPLASTIC SYNDROME IPSS | Patient Inappropriate Chemotherapy With intensity | Age | Comorbidity | Disease Newly Diagnosed
Item
adults with aml (except acute promyelocytic leukaemia (apl)) as defined by the world health organisation (who) classification or patients with high risk mds categorised as int-2 or high risk according to the international prognostic scoring system (ipss) who are deemed ineligible for intensive chemotherapy on the grounds of age or co-morbidities with one of the following disease status:- i) newly diagnosed or
boolean
C0001675 (UMLS CUI [1])
C0023467 (UMLS CUI [2,1])
C1301142 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023487 (UMLS CUI [3,2])
C4319571 (UMLS CUI [4,1])
C3463824 (UMLS CUI [4,2])
C2827405 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
C0522510 (UMLS CUI [5,4])
C0001779 (UMLS CUI [6])
C0009488 (UMLS CUI [7])
C0012634 (UMLS CUI [8,1])
C1518321 (UMLS CUI [8,2])
Recurrent disease | Morphologic Complete Response Previous
Item
ii) relapsed disease: patients must have achieved a previous morphological cr and show evidence of recurrent disease or
boolean
C0277556 (UMLS CUI [1])
C4054467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Refractory Disease | Morphologic Complete Response Failed
Item
iii) refractory disease: patients who have failed to achieve a morphological cr with previous therapy
boolean
C1514815 (UMLS CUI [1])
C4054467 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Ability Outpatient Treatment
Item
patients are able to receive treatment as out-patient
boolean
C0085732 (UMLS CUI [1,1])
C0029921 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Renal function | Liver function
Item
adequate renal and hepatic function as defined in the protocol
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Informed Consent
Item
patients have given written informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Impairment cardiac New York Heart Association Classification
Item
patients with greater than class iii nyha cardiac impairment
boolean
C0221099 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Blast Phase
Item
blastic transformation of chronic myeloid leukaemia
boolean
C0005699 (UMLS CUI [1])
Allogeneic hematopoietic stem cell transplant | Autologous hematopoietic stem cell transplant
Item
prior allogeneic/autologous haematopoietic stem cell transplant
boolean
C4255274 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
adults of reproductive potential not willing to use appropriate, effective, contraception during the trial and for specified amount of time afterwards
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Histone deacetylase inhibitor | Cancer treatment
Item
patients who have received prior histone deacetylase inhibitor (hdaci) treatment as anti-tumour therapy. (patients who have received hdaci treatment for other indications e.g valproic acid for epilepsy may enrol after a 30-day washout period)
boolean
C1512474 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Cancer treatment | Investigational New Drugs | Small Molecule Against Neoplasm | Biological agents
Item
previous anti-tumour therapies, including prior experimental agents or approved anti-tumour small molecules and biologics, within 30 days before the start of protocol treatment. (patients receiving anti-tumour therapies to control blood counts may enrol into the trial)
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0005515 (UMLS CUI [4])
Demethylating Agent | azacitidine | decitabine
Item
patients who have received prior treatment with demethylating agents such as 5-azacitidine or decitabine
boolean
C4329713 (UMLS CUI [1])
C0004475 (UMLS CUI [2])
C0049065 (UMLS CUI [3])
Medical contraindication azacitidine | Medical contraindication vorinostat | Hypersensitivity azacitidine | Hypersensitivity vorinostat | Subcutaneous Injections Receive Unable | Lacking Able to swallow Capsule
Item
patients with contraindications to receiving azacitidine or vorinostat such as hypersensitivity, patients unable to have a subcutaneous injection or swallow oral capsules
boolean
C1301624 (UMLS CUI [1,1])
C0004475 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0672708 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0004475 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0672708 (UMLS CUI [4,2])
C0021499 (UMLS CUI [5,1])
C1514756 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0332268 (UMLS CUI [6,1])
C2712086 (UMLS CUI [6,2])
C0006935 (UMLS CUI [6,3])
Mycoses Symptomatic | Bacterial Infections Symptomatic | Virus Diseases Symptomatic | HIV Infection | Hepatitis A | Hepatitis B | Hepatitis C
Item
active symptomatic fungal, bacterial, and/or viral infection including known active hiv or known viral (a, b, or c) hepatitis
boolean
C0026946 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0004623 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
C0019159 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
Comorbidity Limiting Protocol Compliance
Item
any co-morbidity that could limit compliance with the trial
boolean
C0009488 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
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