Eligibility Acute Myeloid Leukemia NCT02508324

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StudyEvent: Eligibility
1. Eligibility Acute Myeloid Leukemia NCT02508324

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

Patients must be 18 years of age or older

boolean

C0001779 (UMLS CUI [1])

Aml, MDS

Item

Patients with a confirmed diagnosis of aml or mds, according to who classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens. one of the (re-)induction regimens could be stem cell transplantation (sct) for achievement of remission. maintenance and consolidation (including sct) may have been given, but are not counted as previous regimens.

boolean

C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])

Complete remission

Item

have never attained cr or cri (primary refractory)

boolean

C0677874 (UMLS CUI [1])

Induction Therapy

Item

Patients have failed initial induction therapy, and have attained cr or cri after salvage therapy(ies), and then relapsed within < 6 months

boolean

C1514832 (UMLS CUI [1])

Relapse

Item

Patients have attained cr or cri after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies); or have relapsed after the latest cr or cri within < 6 months

boolean

C0035020 (UMLS CUI [1])

Cytarabine

Item

Patients younger than 60 years should have received previous treatment with cytarabine

boolean

C0010711 (UMLS CUI [1])

Ecog performance status

Item

Patients must have ecog performance status (ps) of 0 - 2

boolean

C1520224 (UMLS CUI [1])

Pregnancy test negative

Item

Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start

boolean

C0427780 (UMLS CUI [1])

Complying with protocol

Item

Patients must be capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form

boolean

C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Toxicity due to chemotherapy

Item

Persistent clinically significant toxicities from previous chemotherapy

boolean

C1302255 (UMLS CUI [1])

hiv

Item

Known positive status for human immunodeficiency virus (hiv)

boolean

C0019682 (UMLS CUI [1])

Patient is pregnant

Item

pregnant and nursing patients

boolean

C3242212 (UMLS CUI [1])

Significant Intercurrent Illness

Item

Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements

boolean

C3640977 (UMLS CUI [1])

Impairment of hepatic or renal function

Item

Iimpairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study

boolean

C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])

Heart Diseases

Item

active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. any nyha grade 3 or 4.

boolean

C0018799 (UMLS CUI [1])

Risk for toxicities

Item

Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

boolean

C0525058 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])

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Eligibility Acute Myeloid Leukemia NCT02508324