ID

41058

Beskrivning

Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01191801

Länk

https://clinicaltrials.gov/show/NCT01191801

Nyckelord

Versioner (1)
  1. 2020-06-17 2020-06-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT01191801

Engelsk

Eligibility Leukemia NCT01191801

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01191801
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provide signed, written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
are at least 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have a diagnosis of aml according to world health organization (who) classification
Beskrivning

AML WHO classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C4267671
first relapsed or refractory aml (refractory to initial induction therapy)
Beskrivning

AML First Relapse | AML Unresponsive to Induction Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C4054953
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C0205269
UMLS CUI [2,3]
C0600558
have an ecog score of 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
have adequate liver and renal function as indicated by certain laboratory values
Beskrivning

Liver function | Renal function | Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C1254595
are nonfertile or agree to use an adequate method of contraception until 30 days after the last treatment
Beskrivning

Fertility Absent | Use of Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received more than 2 cycles of induction therapy for aml
Beskrivning

Induction Therapy Quantity AML

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0023467
refractory to or relapsed within the previous 3 months after therapy with an idac- or hidac-containing regimen
Beskrivning

Unresponsive to Treatment | Recurrent disease | Status post IDAC protocol | Status post Cytarabine High dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0205269
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1173669
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0010711
UMLS CUI [4,3]
C0444956
have received a hematopoietic stem cell transplant (hsct) within the previous 3 months
Beskrivning

Hemopoietic stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0472699
have received active immunosuppressive therapy for graft-versus-host disease (gvhd) within 2 weeks before study start
Beskrivning

Therapeutic immunosuppression Graft-vs-Host Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0018133
have any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system
Beskrivning

Comorbidity Severe | Disease Serious | Heart Disease | Kidney Disease | Liver disease | Disease Organ system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0460002
have evidence of central nervous system involvement of active aml
Beskrivning

Central Nervous System Involvement AML

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0023467
have other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
Beskrivning

Cancer Other | Exception Skin carcinoma | Exception Cervical Intraepithelial Neoplasia | Hematologic Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0206708
UMLS CUI [4]
C0376545
have an active, uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
are receiving any other investigational therapy
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
have received previous treatment with vosaroxin
Beskrivning

vosaroxin

Datatyp

boolean

Alias
UMLS CUI [1]
C1451341
are pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
have any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up
Beskrivning

Other medical condition Interferes with Informed Consent | Other medical condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Follow-up | Mental condition Interferes with Informed Consent | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Follow-up | Social situation Interferes with Informed Consent | Social situation Interferes with Study Subject Participation Status | Social situation Interferes with Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C3274571
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
UMLS CUI [5,1]
C3840291
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C3274571
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0021430
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2348568
UMLS CUI [9,1]
C0748872
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C3274571
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Similar models

Eligibility Leukemia NCT01191801

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT01191801
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provide signed, written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
are at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
AML WHO classification
Item
have a diagnosis of aml according to world health organization (who) classification
boolean
C0023467 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
AML First Relapse | AML Unresponsive to Induction Therapy
Item
first relapsed or refractory aml (refractory to initial induction therapy)
boolean
C0023467 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
ECOG performance status
Item
have an ecog score of 0-2
boolean
C1520224 (UMLS CUI [1])
Liver function | Renal function | Laboratory Results
Item
have adequate liver and renal function as indicated by certain laboratory values
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C1254595 (UMLS CUI [3])
Fertility Absent | Use of Contraceptive methods
Item
are nonfertile or agree to use an adequate method of contraception until 30 days after the last treatment
boolean
C0015895 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Induction Therapy Quantity AML
Item
have received more than 2 cycles of induction therapy for aml
boolean
C0600558 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
Unresponsive to Treatment | Recurrent disease | Status post IDAC protocol | Status post Cytarabine High dose
Item
refractory to or relapsed within the previous 3 months after therapy with an idac- or hidac-containing regimen
boolean
C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1173669 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0010711 (UMLS CUI [4,2])
C0444956 (UMLS CUI [4,3])
Hemopoietic stem cell transplant
Item
have received a hematopoietic stem cell transplant (hsct) within the previous 3 months
boolean
C0472699 (UMLS CUI [1])
Therapeutic immunosuppression Graft-vs-Host Disease
Item
have received active immunosuppressive therapy for graft-versus-host disease (gvhd) within 2 weeks before study start
boolean
C0021079 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])
Comorbidity Severe | Disease Serious | Heart Disease | Kidney Disease | Liver disease | Disease Organ system
Item
have any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0460002 (UMLS CUI [6,2])
Central Nervous System Involvement AML
Item
have evidence of central nervous system involvement of active aml
boolean
C4050309 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Cancer Other | Exception Skin carcinoma | Exception Cervical Intraepithelial Neoplasia | Hematologic Neoplasms
Item
have other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0206708 (UMLS CUI [3,2])
C0376545 (UMLS CUI [4])
Communicable Disease Uncontrolled
Item
have an active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Therapy, Investigational
Item
are receiving any other investigational therapy
boolean
C0949266 (UMLS CUI [1])
vosaroxin
Item
have received previous treatment with vosaroxin
boolean
C1451341 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other medical condition Interferes with Informed Consent | Other medical condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Follow-up | Mental condition Interferes with Informed Consent | Mental condition Interferes with Study Subject Participation Status | Mental condition Interferes with Follow-up | Social situation Interferes with Informed Consent | Social situation Interferes with Study Subject Participation Status | Social situation Interferes with Follow-up
Item
have any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C3274571 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
C3840291 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C3274571 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C3274571 (UMLS CUI [9,3])
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