ID

22023

Beschreibung

MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00374296

Link

https://clinicaltrials.gov/show/NCT00374296

Stichworte

Versionen (1)
  1. 15.05.17 15.05.17 -
Hochgeladen am

15. Mai 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Myelogenous Leukemia, Acute NCT00374296

Englisch

Eligibility Myelogenous Leukemia, Acute NCT00374296

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic confirmation of aml or high risk mds.
Beschreibung

Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk

Datentyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2,1]
C3463824
UMLS CUI [2,2]
C0332167
elderly cohort (70 years of age or more): no prior chemotherapy treatment for aml/high risk mds and not currently candidates for intensive chemotherapy.
Beschreibung

Cohort Elderly | Age | Chemotherapy Acute Myelocytic Leukemia | Chemotherapy MYELODYSPLASTIC SYNDROME High risk | Chemotherapy With intensity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0001792
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0023467
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C3463824
UMLS CUI [4,3]
C0332167
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0522510
relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
Beschreibung

Cohort Relapse Refractory | Age | Relapse | Refractory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0599755
UMLS CUI [1,2]
C0035020
UMLS CUI [1,3]
C0205269
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0035020
UMLS CUI [4]
C0205269
ecog performance status of 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
total bilirubin < 1.5 x upper limit of normal (uln).
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
ast/sgot and alt/sgpt < 2.5 x uln.
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine < 1.5 x uln.
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
patients must read, understand, and sign a written informed consent form (icf).
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.
Beschreibung

Childbearing Potential Contraceptive methods | Gender Partner Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating women.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5c (not due to tumor fever) on the day of scheduled dosing.
Beschreibung

Comorbidity Uncontrolled | Communicable Diseases | Communicable Diseases Uncontrolled | Fever | Tumour associated fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0015967
UMLS CUI [5]
C0948348
patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
Beschreibung

Illness Serious Interferes with Study Subject Participation Status | Illness Serious Interferes with research results | Medical condition Serious Interferes with Study Subject Participation Status | Medical condition Serious Interferes with research results | Laboratory Results Interfere with Study Subject Participation Status | Laboratory Results Interfere with research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0683954
UMLS CUI [5,1]
C1254595
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C1254595
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0683954
patients treated with an investigational drug within 30 days prior to study initiation.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
known hypersensitivity to hdac inhibitors or to any of the components of mg-0103.
Beschreibung

Hypersensitivity Histone deacetylase inhibitor | Hypersensitivity MG 0103 Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1512474
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1831851
UMLS CUI [2,3]
C1705248
known hiv or active hepatitis b or c.
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
any condition that may affect the patient's ability to sign the icf and undergo study procedures.
Beschreibung

Condition Affecting Informed Consent | Condition Affecting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
Beschreibung

Condition Resulting in Patient Risk | Condition Resulting in Patient Discomfort | Protocol Compliance Consequence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C0035647
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C2364135
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0686907
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Ähnliche Modelle

Eligibility Myelogenous Leukemia, Acute NCT00374296

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk
Item
pathologic confirmation of aml or high risk mds.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
Cohort Elderly | Age | Chemotherapy Acute Myelocytic Leukemia | Chemotherapy MYELODYSPLASTIC SYNDROME High risk | Chemotherapy With intensity
Item
elderly cohort (70 years of age or more): no prior chemotherapy treatment for aml/high risk mds and not currently candidates for intensive chemotherapy.
boolean
C0599755 (UMLS CUI [1,1])
C0001792 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0023467 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C3463824 (UMLS CUI [4,2])
C0332167 (UMLS CUI [4,3])
C0392920 (UMLS CUI [5,1])
C0522510 (UMLS CUI [5,2])
Cohort Relapse Refractory | Age | Relapse | Refractory
Item
relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
boolean
C0599755 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0001779 (UMLS CUI [2])
C0035020 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x upper limit of normal (uln).
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/sgot and alt/sgpt < 2.5 x uln.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine < 1.5 x uln.
boolean
C0201976 (UMLS CUI [1])
Informed Consent
Item
patients must read, understand, and sign a written informed consent form (icf).
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Partner Contraceptive methods
Item
women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Diseases | Communicable Diseases Uncontrolled | Fever | Tumour associated fever
Item
patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5c (not due to tumor fever) on the day of scheduled dosing.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0015967 (UMLS CUI [4])
C0948348 (UMLS CUI [5])
Illness Serious Interferes with Study Subject Participation Status | Illness Serious Interferes with research results | Medical condition Serious Interferes with Study Subject Participation Status | Medical condition Serious Interferes with research results | Laboratory Results Interfere with Study Subject Participation Status | Laboratory Results Interfere with research results
Item
patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2348568 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0683954 (UMLS CUI [4,4])
C1254595 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C1254595 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0683954 (UMLS CUI [6,3])
Investigational New Drugs
Item
patients treated with an investigational drug within 30 days prior to study initiation.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Histone deacetylase inhibitor | Hypersensitivity MG 0103 Component
Item
known hypersensitivity to hdac inhibitors or to any of the components of mg-0103.
boolean
C0020517 (UMLS CUI [1,1])
C1512474 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1831851 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
known hiv or active hepatitis b or c.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Condition Affecting Informed Consent | Condition Affecting Protocol Compliance
Item
any condition that may affect the patient's ability to sign the icf and undergo study procedures.
boolean
C0348080 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Condition Resulting in Patient Risk | Condition Resulting in Patient Discomfort | Protocol Compliance Consequence of
Item
any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0035647 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C2364135 (UMLS CUI [2,4])
C0525058 (UMLS CUI [3,1])
C0686907 (UMLS CUI [3,2])
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