Informações:
Falhas:
ID
13245
Descrição
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
Palavras-chave
Versões (1)
- 26/01/2016 26/01/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
26 de janeiro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT02203773
Eligibility Acute Myelogenous Leukemia NCT02203773
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myelogenous Leukemia NCT02203773
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
C1504389 (UMLS CUI [2])