ID

13245

Description

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

Link

https://clinicaltrials.gov/show/NCT02203773

Keywords

Versions (1)
  1. 1/26/16 1/26/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 26, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT02203773

English

Eligibility Acute Myelogenous Leukemia NCT02203773

1 forms  
Inclusion Criteria
Description

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.
Description

AML

Data type

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).
Description

prior treatment

Data type

boolean

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

ECOG

Data type

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.
Description

renal function

Data type

boolean

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

liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

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

hypomethylating agent and/or cytarabine

Data type

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.
Description

risk cytogenetics

Data type

boolean

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

karyotype abnormalities

Data type

boolean

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

APL

Data type

boolean

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

CNS Leukemia

Data type

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.
Description

CYP3A interactions, warfarin

Data type

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.
Description

prior malignancy

Data type

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.
Description

leukocytes

Data type

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.
Description

one marrow or stem cell transplant

Data type

boolean

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

Eligibility Acute Myelogenous Leukemia NCT02203773

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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