AML WHO classification | Unresponsive to Prior Therapy | Recurrent disease Post Prior Therapy | MYELODYSPLASTIC SYNDROME | Leukemia, Myelomonocytic, Chronic | Hypomethylation Therapy | Disease Progression AML | Unresponsive to Treatment
Item
1. patients with aml who have either been refractory to prior therapy or have relapsed after prior therapy. patients with mds or cmml who received therapy with a hypomethylating agent and progress to aml are eligible if they have received any therapy for mds and failed (i.e., lack or loss of response) regardless of whether they have received therapy for aml or not. the who classification will be used for aml.
boolean
C0023467 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C3463824 (UMLS CUI [4])
C0023480 (UMLS CUI [5])
C4054751 (UMLS CUI [6])
C0242656 (UMLS CUI [7,1])
C0023467 (UMLS CUI [7,2])
C0205269 (UMLS CUI [8])
Age
Item
2. age >/=18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status </=2
boolean
C1520224 (UMLS CUI [1])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
4. adequate liver (total bilirubin </=2x uln, alt </=2.5x uln) and renal (creatinine </=2x uln) function.
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Informed Consent
Item
5. patients must provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Chemotherapy Absent | Exception Rapid disease progression | Toxicity Due to Therapeutic procedure | Patient recovered CTCAE Grades | Hydroxyurea allowed Rapid disease progression
Item
6. patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1. use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1834700 (UMLS CUI [2,2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4,1])
C1516728 (UMLS CUI [4,2])
C0020402 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C1834700 (UMLS CUI [5,3])
Females & males of reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
7. patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
Hypersensitivity Erlotinib
Item
1. patients with known allergy or hypersensitivity to erlotinib.
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
Comorbidity Severe At risk Study Subject Participation Status | Exception Carcinoma in Situ | Medical condition Uncontrolled | Diabetic - poor control | Cardiovascular Disease | Congestive heart failure New York Heart Association Classification | Myocardial Infarction | Poor hypertension control | Kidney Failure, Chronic | Communicable Disease Uncontrolled
Item
2. patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure nyha class iii or iv, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0421258 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0027051 (UMLS CUI [7])
C0421190 (UMLS CUI [8])
C0022661 (UMLS CUI [9])
C0009450 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
3. patients unwilling or unable to comply with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Gastrointestinal Diseases Interfere with Absorption Erlotinib
Item
4. significant gastrointestinal disorders that may interfere with absorption of erlotinib.
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C1135135 (UMLS CUI [1,4])
Ability Stem cell transplant Receive
Item
5. patients who can receive a stem cell transplant within 4 weeks.
boolean
C0085732 (UMLS CUI [1,1])
C1504389 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])