ID

13245

Beskrivning

Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo); ODM derived from: https://clinicaltrials.gov/show/NCT02203773

Länk

https://clinicaltrials.gov/show/NCT02203773

Nyckelord

  1. 2016-01-26 2016-01-26 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

26 januari 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Acute Myelogenous Leukemia NCT02203773

Eligibility Acute Myelogenous Leukemia NCT02203773

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects must have histological confirmation of aml by who criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
Beskrivning

AML

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
2. subjects must have received no prior treatment for aml with the exception of hydroxyurea, allowed through the first cycle of study treatment. note: subject may have been treated for prior myelodysplastic syndrome (excluding hypomethylating agents).
Beskrivning

prior treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
3. subjects must have an eastern cooperative oncology group (ecog) performance status of 0 to 2.
Beskrivning

ECOG

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. 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.
Beskrivning

renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
5. subject must have adequate liver function.
Beskrivning

liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has received treatment with a hypomethylating agent and/or cytarabine for a pre-existing myeloid disorder.
Beskrivning

hypomethylating agent and/or cytarabine

Datatyp

boolean

Alias
UMLS CUI [1]
C0010711
2. subject must not have favorable risk cytogenetics as categorized by the nccn guidelines version 2, 2014 for acute myeloid leukemia.
Beskrivning

risk cytogenetics

Datatyp

boolean

Alias
UMLS CUI [1]
C0010802
3. subject has t(8;21), inv(16) or t(15;17) karyotype abnormalities.
Beskrivning

karyotype abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C1261273
4. subject has acute promyelocytic leukemia (french-american-british class m3 aml).
Beskrivning

APL

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
5. subject has known active cns involvement with aml.
Beskrivning

CNS Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
6. subject has received the following within 7 days prior to the initiation of study treatment: potent cyp3a inducers such as rifampin, carbamazepine, phenytoin, and st. john's wort; warfarin or requires the use of warfarin and its equivalent drugs, such as phenprocoumon; (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of anticoagulant effect). cyp3a inhibitors such as fluconazole, ketoconazole, and clarithromycin.
Beskrivning

CYP3A interactions, warfarin

Datatyp

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C3830625
UMLS CUI [3]
C0043031
7. subject has a history of other malignancies prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Beskrivning

prior malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
8. subject has a white blood cell count > 25 × 10^9/l. note: hydroxyurea is permitted to meet this criterion.
Beskrivning

leukocytes

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
9. subject is a candidate for a bone marrow or stem cell transplant within 12 weeks after study enrollment.
Beskrivning

one marrow or stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1]
C0005961
UMLS CUI [2]
C1504389

Similar models

Eligibility Acute Myelogenous Leukemia NCT02203773

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
1. subjects must have histological confirmation of aml by who criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
boolean
C0023467 (UMLS CUI [1])
prior treatment
Item
2. subjects must have received no prior treatment for aml with the exception of hydroxyurea, allowed through the first cycle of study treatment. note: subject may have been treated for prior myelodysplastic syndrome (excluding hypomethylating agents).
boolean
C0087111 (UMLS CUI [1])
ECOG
Item
3. subjects must have an eastern cooperative oncology group (ecog) performance status of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
renal function
Item
4. 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.
boolean
C0373595 (UMLS CUI [1])
liver function
Item
5. subject must have adequate liver function.
boolean
C0232741 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypomethylating agent and/or cytarabine
Item
1. subject has received treatment with a hypomethylating agent and/or cytarabine for a pre-existing myeloid disorder.
boolean
C0010711 (UMLS CUI [1])
risk cytogenetics
Item
2. subject must not have favorable risk cytogenetics as categorized by the nccn guidelines version 2, 2014 for acute myeloid leukemia.
boolean
C0010802 (UMLS CUI [1])
karyotype abnormalities
Item
3. subject has t(8;21), inv(16) or t(15;17) karyotype abnormalities.
boolean
C1261273 (UMLS CUI [1])
APL
Item
4. subject has acute promyelocytic leukemia (french-american-british class m3 aml).
boolean
C0023487 (UMLS CUI [1])
CNS Leukemia
Item
5. subject has known active cns involvement with aml.
boolean
C1332884 (UMLS CUI [1])
CYP3A interactions, warfarin
Item
6. subject has received the following within 7 days prior to the initiation of study treatment: potent cyp3a inducers such as rifampin, carbamazepine, phenytoin, and st. john's wort; warfarin or requires the use of warfarin and its equivalent drugs, such as phenprocoumon; (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of anticoagulant effect). cyp3a inhibitors such as fluconazole, ketoconazole, and clarithromycin.
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
prior malignancy
Item
7. subject has a history of other malignancies prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
boolean
C0006826 (UMLS CUI [1])
leukocytes
Item
8. subject has a white blood cell count > 25 × 10^9/l. note: hydroxyurea is permitted to meet this criterion.
boolean
C0023508 (UMLS CUI [1])
one marrow or stem cell transplant
Item
9. subject is a candidate for a bone marrow or stem cell transplant within 12 weeks after study enrollment.
boolean
C0005961 (UMLS CUI [1])
C1504389 (UMLS CUI [2])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial