ID

4489

Description

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00006045

Link

http://clinicaltrials.gov/ct2/show/record/NCT00006045

Keywords

Versions (5)
  1. 09/12/13 09/12/13 - Martin Dugas
  2. 25/03/14 25/03/14 - Martin Dugas
  3. 11/04/14 11/04/14 - Julian Varghese
  4. 11/04/14 11/04/14 - Julian Varghese
  5. 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

9 dicembre 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00006045 AML

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
DISEASE CHARACTERISTICS
Description

DISEASE CHARACTERISTICS

Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
Description

AML

Data type

boolean

All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
Description

except M3

Data type

boolean

First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
Description

First relapse

Data type

boolean

No transplantation candidates
Description

BMT

Data type

boolean

Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
Description

Blasts

Data type

boolean

No active CNS leukemia
Description

CNS leukemia

Data type

boolean

PATIENT CHARACTERISTICS
Description

PATIENT CHARACTERISTICS

Age: 18 and over
Description

Age

Data type

boolean

Karnofsky 50-100%
Description

Performance status

Data type

boolean

Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
Description

Hepatic

Data type

boolean

SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML)
Description

SGOT, SGPT

Data type

boolean

Creatinine less than 2.0 mg/dL (unless related to AML)
Description

Renal

Data type

boolean

Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
Description

Cardiovascular

Data type

boolean

Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study
Description

Pregnancy, Nursing

Data type

boolean

HIV negative
Description

HIV negative

Data type

boolean

No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
Description

other

Data type

boolean

PRIOR CONCURRENT THERAPY
Description

PRIOR CONCURRENT THERAPY

Characteristics At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
Description

Biologic therapy

Data type

boolean

For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
Description

Chemotherapy

Data type

boolean

No concurrent radiotherapy
Description

Radiotherapy

Data type

boolean

No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
Description

Other

Data type

boolean

Medical Concepts
Description

Medical Concepts

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
Acute myeloid leukemia
Description

AML

Data type

string

Alias
UMLS CUI
C0023467
SNOMED CT 2010_0731
91861009
MedDRA 13.1
10000880
ICD-10-CM Version 2010
C92.0
ICD-9-CM Version 2011
205.0
Acute Promyelocytic Leukemia
Description

APL

Data type

string

Alias
UMLS CUI
C0023487
SNOMED CT 2010_0731
110004001
MedDRA 13.1
10001019
ICD-10-CM Version 2010
C92.4
complete remission
Description

CR

Data type

string

Alias
UMLS CUI
C0677874
SNOMED CT 2010_0731
103338009
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Recurrent Disease
Description

Relapse

Data type

string

Alias
UMLS CUI
C0277556
SNOMED CT 2010_0731
58184002
Bone Marrow Transplantation
Description

BMT

Data type

string

Alias
UMLS CUI
C0005961
SNOMED CT 2010_0731
23719005
MedDRA 13.1
10061730
ICD-9-CM Version 2011
41.00
Bone Marrow Cellularity Adverse Event
Description

Bone marrow cellularity

Data type

string

Alias
UMLS CUI
C1561532
Hemoglobin
Description

Hemoglobin

Data type

string

Alias
UMLS CUI
C0019046
SNOMED CT 2010_0731
38082009
MedDRA 13.1
10019481
LOINC Version 232
LP14449-0
Platelet count - finding
Description

Platelet count

Data type

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Absolute Neutrophil Count
Description

Absolute Neutrophil Count

Data type

string

Alias
UMLS CUI
C0948762
MedDRA 13.1
10052033
Chronic myeloid leukemia
Description

CML

Data type

string

Alias
UMLS CUI
C0023473
SNOMED CT 2010_0731
63364005
MedDRA 13.1
10009700
ICD-10-CM Version 2010
C92.1
ICD-9-CM Version 2011
205.1
Blast phase
Description

Blast crisis

Data type

string

Alias
UMLS CUI
C0005699
SNOMED CT 2010_0731
278180008
MedDRA 13.1
10053747
Central Nervous System Leukemia
Description

CNS leukemia

Data type

string

Alias
UMLS CUI
C1332884
MedDRA 13.1
10067299
Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Karnofsky performance status
Description

Karnofsky

Data type

string

Alias
UMLS CUI
C0206065
SNOMED CT 2010_0731
273546003
Bilirubin
Description

Bilirubin

Data type

string

Alias
UMLS CUI
C0011221
SNOMED CT 2010_0731
79706000
LOINC Version 232
1975-2
GPT
Description

ALT

Data type

string

Alias
UMLS CUI
C0001899
SNOMED CT 2010_0731
56935002
MedDRA 13.1
10001844
GOT
Description

AST

Data type

string

Alias
UMLS CUI
C0004002
SNOMED CT 2010_0731
26091008
MedDRA 13.1
10003543
Creatinine
Description

Creatinine

Data type

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
MedDRA 13.1
10011358
LOINC Version 232
38483-4
Cardiac disorder
Description

Heart Diseases

Data type

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
HIV negative
Description

HIV negative

Data type

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
MedDRA 13.1
10020179
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C1516879
Radiotherapy
Description

Radiotherapy

Data type

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
DISEASE CHARACTERISTICS
AML
Item
Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
boolean
except M3
Item
All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
boolean
First relapse
Item
First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
boolean
BMT
Item
No transplantation candidates
boolean
Blasts
Item
Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
boolean
CNS leukemia
Item
No active CNS leukemia
boolean
Item Group
PATIENT CHARACTERISTICS
Age
Item
Age: 18 and over
boolean
Performance status
Item
Karnofsky 50-100%
boolean
Hepatic
Item
Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
boolean
SGOT, SGPT
Item
SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML)
boolean
Renal
Item
Creatinine less than 2.0 mg/dL (unless related to AML)
boolean
Cardiovascular
Item
Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
boolean
Pregnancy, Nursing
Item
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study
boolean
HIV negative
Item
HIV negative
boolean
other
Item
No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
boolean
Item Group
PRIOR CONCURRENT THERAPY
Biologic therapy
Item
Characteristics At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
boolean
Chemotherapy
Item
For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
boolean
Radiotherapy
Item
No concurrent radiotherapy
boolean
Other
Item
No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
boolean
Item Group
Medical Concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
AML
Item
Acute myeloid leukemia
string
C0023467 (UMLS CUI)
91861009 (SNOMED CT 2010_0731)
10000880 (MedDRA 13.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
APL
Item
Acute Promyelocytic Leukemia
string
C0023487 (UMLS CUI)
110004001 (SNOMED CT 2010_0731)
10001019 (MedDRA 13.1)
C92.4 (ICD-10-CM Version 2010)
CR
Item
complete remission
string
C0677874 (UMLS CUI)
103338009 (SNOMED CT 2010_0731)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Relapse
Item
Recurrent Disease
string
C0277556 (UMLS CUI)
58184002 (SNOMED CT 2010_0731)
BMT
Item
Bone Marrow Transplantation
string
C0005961 (UMLS CUI)
23719005 (SNOMED CT 2010_0731)
10061730 (MedDRA 13.1)
41.00 (ICD-9-CM Version 2011)
Bone marrow cellularity
Item
Bone Marrow Cellularity Adverse Event
string
C1561532 (UMLS CUI)
Hemoglobin
Item
Hemoglobin
string
C0019046 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Absolute Neutrophil Count
Item
Absolute Neutrophil Count
string
C0948762 (UMLS CUI)
10052033 (MedDRA 13.1)
CML
Item
Chronic myeloid leukemia
string
C0023473 (UMLS CUI)
63364005 (SNOMED CT 2010_0731)
10009700 (MedDRA 13.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
Blast crisis
Item
Blast phase
string
C0005699 (UMLS CUI)
278180008 (SNOMED CT 2010_0731)
10053747 (MedDRA 13.1)
CNS leukemia
Item
Central Nervous System Leukemia
string
C1332884 (UMLS CUI)
10067299 (MedDRA 13.1)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Karnofsky
Item
Karnofsky performance status
string
C0206065 (UMLS CUI)
273546003 (SNOMED CT 2010_0731)
Bilirubin
Item
Bilirubin
string
C0011221 (UMLS CUI)
79706000 (SNOMED CT 2010_0731)
1975-2 (LOINC Version 232)
ALT
Item
GPT
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
AST
Item
GOT
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
Heart Diseases
Item
Cardiac disorder
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
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