ID

14153

Description

Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02462265

Link

https://clinicaltrials.gov/show/NCT02462265

Keywords

  1. 4/1/16 4/1/16 -
Uploaded on

April 1, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Myeloid Leukemia NCT02462265

Eligibility Acute Myeloid Leukemia NCT02462265

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients is diagnosed as aml or all
Description

aml or all

Data type

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C0023449
relapse defined as the presence of disease after the achievement of complete remission(cr). refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
Description

Relapse AML

Data type

boolean

Alias
UMLS CUI [1]
C2367456
male or female ≥ 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
minimal performance status (ecog 0, ≤2)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
Description

bone marrow blast count

Data type

boolean

Alias
UMLS CUI [1]
C2697913
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adequate hepatic function (lfts up to x4 the normal limits), renal function calculated creatinine clearance (crcl) for adverse effects of >30)
Description

Liver and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ability to swallow the medications.
Description

Ability to swallow tablet

Data type

boolean

Alias
UMLS CUI [1]
C3838726
females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infectious disease uncontrolled by antibiotics.
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
partially treated induction patients (i.e. day 14 non responding patients).
Description

Induction patients

Data type

boolean

Alias
UMLS CUI [1]
C0205263
Inability to receive high dose salvage chemotherapy.
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C3665472
patient with known positive hiv serology at screening.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
Description

Breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C1623040
UMLS CUI [2]
C0240802
evidence of ongoing cardiac dysrhythmias of nci common toxicity criteria for adverse effects (ctcae ) version 3.0 grade 2.
Description

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
Description

Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0022104
mental disorders
Description

mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
inability to give written informed consent
Description

No written consent

Data type

boolean

Alias
UMLS CUI [1]
C0811746

Similar models

Eligibility Acute Myeloid Leukemia NCT02462265

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
aml or all
Item
patients is diagnosed as aml or all
boolean
C0023467 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
Relapse AML
Item
relapse defined as the presence of disease after the achievement of complete remission(cr). refractory disease is defined as progression from or no response while treated with a previous line chemotherapy regimen, or progression within 30 days of last bone marrow assessment.
boolean
C2367456 (UMLS CUI [1])
Age
Item
male or female ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
minimal performance status (ecog 0, ≤2)
boolean
C1520224 (UMLS CUI [1])
bone marrow blast count
Item
patients must have a measurable disease by bone marrow blast counts of > 5 % of nucleated cells.
boolean
C2697913 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Liver and renal function
Item
adequate hepatic function (lfts up to x4 the normal limits), renal function calculated creatinine clearance (crcl) for adverse effects of >30)
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Ability to swallow tablet
Item
ability to swallow the medications.
boolean
C3838726 (UMLS CUI [1])
Contraceptive methods
Item
females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
boolean
C0700589 (UMLS CUI [1])
Pregnancy test negative
Item
females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases
Item
active infectious disease uncontrolled by antibiotics.
boolean
C0009450 (UMLS CUI [1])
Induction patients
Item
partially treated induction patients (i.e. day 14 non responding patients).
boolean
C0205263 (UMLS CUI [1])
Chemotherapy
Item
Inability to receive high dose salvage chemotherapy.
boolean
C3665472 (UMLS CUI [1])
HIV Seropositivity
Item
patient with known positive hiv serology at screening.
boolean
C0019699 (UMLS CUI [1])
Breastfeeding
Item
female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
boolean
C1623040 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Cardiac Arrhythmia
Item
evidence of ongoing cardiac dysrhythmias of nci common toxicity criteria for adverse effects (ctcae ) version 3.0 grade 2.
boolean
C0003811 (UMLS CUI [1])
Malabsorption Syndrome
Item
pre-existing malabsorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
boolean
C0024523 (UMLS CUI [1])
C0022104 (UMLS CUI [2])
mental disorders
Item
mental disorders
boolean
C0004936 (UMLS CUI [1])
No written consent
Item
inability to give written informed consent
boolean
C0811746 (UMLS CUI [1])

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