ID

41125

Beskrivning

Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00906945

Länk

https://clinicaltrials.gov/show/NCT00906945

Nyckelord

Versioner (1)
  1. 2020-06-27 2020-06-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 juni 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Leukemia, Myeloid, Acute NCT00906945

Engelsk

Eligibility Leukemia, Myeloid, Acute NCT00906945

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. acute myeloid leukemia diagnosed by who criteria with one of the following:
Beskrivning

AML WHO tumor classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1301142
primary refractory disease following no more than 2 cycles of induction chemotherapy
Beskrivning

Refractory Disease | Status post Induction Chemotherapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1514815
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C3179010
UMLS CUI [2,3]
C1265611
first relapse with no prior unsuccessful salvage chemotherapy
Beskrivning

First Relapse | Absence Prior Chemotherapy Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C4054953
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1514457
UMLS CUI [2,3]
C1272705
2. age between 18 and 70 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. ecog performance status ≤ 3
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate organ function defined as:
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
calculated creatinine clearance ≥ 50 ml/min
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
ast, alt, total bilirubin ≤ 2 x uln except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Due to Leukemia | Exception Leukemic infiltration hepatic | Exception Obstruction of biliary tree Due to Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0023418
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1142074
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0400979
UMLS CUI [6,3]
C0678226
UMLS CUI [6,4]
C0023418
left ventricular ejection fraction of ≥ 40% by muga scan or echocardiogram
Beskrivning

Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
5. are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
Beskrivning

Infertility | Sexual sterilization | Contraceptive methods Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C0021359
UMLS CUI [2]
C0038288
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0600109
females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. acceptable methods of birth control include oral contraceptive, intrauterine device (iud), transdermal/implanted or injected contraceptives and abstinence.
Beskrivning

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Contraceptives, Oral | Intrauterine Devices | Transdermal contraception | Contraceptive implant | Injectable contraception | Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
UMLS CUI [5]
C0009905
UMLS CUI [6]
C0021900
UMLS CUI [7]
C1168146
UMLS CUI [8]
C1657106
UMLS CUI [9]
C1262153
UMLS CUI [10]
C0036899
males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
Beskrivning

Gender Sexual Abstinence | Gender Contraceptive methods Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0600109
6. able to provide signed informed consent prior to registration on study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute promyelocytic leukemia (aml with t(15;17)(q22;q11) and variants)
Beskrivning

Acute Promyelocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
2. peripheral blood blast count ≥ 20 x 103 /mm3
Beskrivning

Blast count Peripheral blood

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0523113
UMLS CUI [1,2]
C0229664
3. active cns involvement with leukemia
Beskrivning

Central nervous system leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
4. previous treatment with mec or other regimen containing both mitoxantrone and etoposide
Beskrivning

MEC regimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0286540
5. pregnant or nursing
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
Beskrivning

Investigational New Drugs | Cytotoxic Chemotherapy | Exception hydroxyurea

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0677881
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020402
7. received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
Beskrivning

filgrastim | sargramostim | pegfilgrastim

Datatyp

boolean

Alias
UMLS CUI [1]
C0210630
UMLS CUI [2]
C0216231
UMLS CUI [3]
C1136535
8. severe concurrent illness that would limit compliance with study requirements
Beskrivning

Comorbidity Severe Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0525058
Tillbaka till toppen

Similar models

Eligibility Leukemia, Myeloid, Acute NCT00906945

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML WHO tumor classification
Item
1. acute myeloid leukemia diagnosed by who criteria with one of the following:
boolean
C0023467 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Refractory Disease | Status post Induction Chemotherapy Quantity
Item
primary refractory disease following no more than 2 cycles of induction chemotherapy
boolean
C1514815 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C3179010 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
First Relapse | Absence Prior Chemotherapy Unsuccessful
Item
first relapse with no prior unsuccessful salvage chemotherapy
boolean
C4054953 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C1514457 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Age
Item
2. age between 18 and 70 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status ≤ 3
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
4. adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance ≥ 50 ml/min
boolean
C2711451 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Exception Due to Leukemia | Exception Leukemic infiltration hepatic | Exception Obstruction of biliary tree Due to Leukemia
Item
ast, alt, total bilirubin ≤ 2 x uln except when in the opinion of treating physician is due to direct involvement of leukemia (eg. hepatic infiltration or biliary obstruction due to leukemia)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0023418 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1142074 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0400979 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0023418 (UMLS CUI [6,4])
Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction Echocardiography
Item
left ventricular ejection fraction of ≥ 40% by muga scan or echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Infertility | Sexual sterilization | Contraceptive methods Willing
Item
5. are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
boolean
C0021359 (UMLS CUI [1])
C0038288 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0600109 (UMLS CUI [3,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Contraceptives, Oral | Intrauterine Devices | Transdermal contraception | Contraceptive implant | Injectable contraception | Sexual Abstinence
Item
females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. women of child bearing potential must have a negative serum or urine pregnancy test at the time of enrollment. acceptable methods of birth control include oral contraceptive, intrauterine device (iud), transdermal/implanted or injected contraceptives and abstinence.
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C1168146 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1262153 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
Gender Sexual Abstinence | Gender Contraceptive methods Willing
Item
males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period
boolean
C0079399 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Informed Consent
Item
6. able to provide signed informed consent prior to registration on study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Promyelocytic Leukemia
Item
1. acute promyelocytic leukemia (aml with t(15;17)(q22;q11) and variants)
boolean
C0023487 (UMLS CUI [1])
Blast count Peripheral blood
Item
2. peripheral blood blast count ≥ 20 x 103 /mm3
boolean
C0523113 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Central nervous system leukemia
Item
3. active cns involvement with leukemia
boolean
C1332884 (UMLS CUI [1])
MEC regimen
Item
4. previous treatment with mec or other regimen containing both mitoxantrone and etoposide
boolean
C0286540 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
5. pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Cytotoxic Chemotherapy | Exception hydroxyurea
Item
6. received any other investigational agent or cytotoxic chemotherapy (excluding hydroxyurea) within the preceding 2 weeks
boolean
C0013230 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0020402 (UMLS CUI [3,2])
filgrastim | sargramostim | pegfilgrastim
Item
7. received colony stimulating factors filgrastim or sargramostim within 1 week or pegfilgrastim within 2 weeks of study
boolean
C0210630 (UMLS CUI [1])
C0216231 (UMLS CUI [2])
C1136535 (UMLS CUI [3])
Comorbidity Severe Limiting Protocol Compliance
Item
8. severe concurrent illness that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial