ID

41125

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00906945

Stichworte

Versionen (1)
  1. 27.06.20 27.06.20 -
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See clinicaltrials.gov

Hochgeladen am

27. Juni 2020

DOI

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Eligibility Leukemia, Myeloid, Acute NCT00906945

Englisch

Eligibility Leukemia, Myeloid, Acute NCT00906945

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

AML WHO tumor classification

Datentyp

boolean

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

Refractory Disease | Status post Induction Chemotherapy Quantity

Datentyp

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
Beschreibung

First Relapse | Absence Prior Chemotherapy Unsuccessful

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Organ function

Datentyp

boolean

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

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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:
Beschreibung

Infertility | Sexual sterilization | Contraceptive methods Willing

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Gender Sexual Abstinence | Gender Contraceptive methods Willing

Datentyp

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
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Acute Promyelocytic Leukemia

Datentyp

boolean

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

Blast count Peripheral blood

Datentyp

boolean

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

Central nervous system leukemia

Datentyp

boolean

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

MEC regimen

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

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
Beschreibung

Investigational New Drugs | Cytotoxic Chemotherapy | Exception hydroxyurea

Datentyp

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
Beschreibung

filgrastim | sargramostim | pegfilgrastim

Datentyp

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
Beschreibung

Comorbidity Severe Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0525058
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Ähnliche Modelle

Eligibility Leukemia, Myeloid, Acute NCT00906945

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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