Eligibility Acute Myelogenous Leukemia NCT01994837

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological or cytological confirmation of relapsed or refractory aml (by world health organization (who) classification) or untreated aml in patients who are unfit for intensive therapy.
Descrizione

AML

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023467
2. subject has an eastern cooperative oncology group (ecog) performance score of 0 to 2.
Descrizione

ECOG

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
3. subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 ml/min; determined via urine collection for 24-hour creatinine clearance or by the cockcroft gault formula using ideal body mass (ibm) instead of mass.
Descrizione

renal function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0373595
4. subject must have adequate liver function.
Descrizione

liver function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has received acute anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of abt-199.
Descrizione

anti-cancer therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
UMLS CUI [4]
C1875319
2. subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
Descrizione

monoclonal antibody

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003250
3. subject has received potent cyp3a inducers (such as rifampin, carbamazepine, phenytoin and st. john's wort and warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect) within 7 days prior to the first dose of study drug.
Descrizione

CYP3A inducer

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0059563
4. subject has received cyp3a inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 5 days prior to the first dose of study drug.
Descrizione

cyp3a inhibitors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0059563
5. subject has a white blood cell count > 25 x 10^9/l.
Descrizione

leukocytes

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023508
6. subject has acute promyelocytic leukemia (french-american-british class m3 aml).
Descrizione

APL

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023487
7. subjects with known active cns disease.
Descrizione

cns leukemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1332884

Similar models

Eligibility Acute Myelogenous Leukemia NCT01994837

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
1. histological or cytological confirmation of relapsed or refractory aml (by world health organization (who) classification) or untreated aml in patients who are unfit for intensive therapy.
boolean
C0023467 (UMLS CUI [1])
ECOG
Item
2. subject has an eastern cooperative oncology group (ecog) performance score of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
renal function
Item
3. subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 ml/min; determined via urine collection for 24-hour creatinine clearance or by the cockcroft gault formula using ideal body mass (ibm) instead of mass.
boolean
C0373595 (UMLS CUI [1])
liver function
Item
4. subject must have adequate liver function.
boolean
C0232741 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
anti-cancer therapy
Item
1. subject has received acute anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of abt-199.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C1875319 (UMLS CUI [4])
monoclonal antibody
Item
2. subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
boolean
C0003250 (UMLS CUI [1])
CYP3A inducer
Item
3. subject has received potent cyp3a inducers (such as rifampin, carbamazepine, phenytoin and st. john's wort and warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect) within 7 days prior to the first dose of study drug.
boolean
C0059563 (UMLS CUI [1])
cyp3a inhibitors
Item
4. subject has received cyp3a inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 5 days prior to the first dose of study drug.
boolean
C0059563 (UMLS CUI [1])
leukocytes
Item
5. subject has a white blood cell count > 25 x 10^9/l.
boolean
C0023508 (UMLS CUI [1])
APL
Item
6. subject has acute promyelocytic leukemia (french-american-british class m3 aml).
boolean
C0023487 (UMLS CUI [1])
cns leukemia
Item
7. subjects with known active cns disease.
boolean
C1332884 (UMLS CUI [1])