AML
Item
Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
boolean
except M3
Item
All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
boolean
First relapse
Item
First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
boolean
BMT
Item
No transplantation candidates
boolean
Blasts
Item
Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
boolean
CNS leukemia
Item
No active CNS leukemia
boolean
Age
Item
Age: 18 and over
boolean
Performance status
Item
Karnofsky 50-100%
boolean
Hepatic
Item
Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
boolean
SGOT, SGPT
Item
SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML)
boolean
Renal
Item
Creatinine less than 2.0 mg/dL (unless related to AML)
boolean
Cardiovascular
Item
Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
boolean
Pregnancy, Nursing
Item
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study
boolean
HIV negative
Item
HIV negative
boolean
other
Item
No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
boolean
Biologic therapy
Item
Characteristics At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
boolean
Chemotherapy
Item
For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
boolean
Radiotherapy
Item
No concurrent radiotherapy
boolean
Other
Item
No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
boolean
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
AML
Item
Acute myeloid leukemia
string
C0023467 (UMLS CUI)
91861009 (SNOMED CT 2010_0731)
10000880 (MedDRA 13.1)
C92.0 (ICD-10-CM Version 2010)
205.0 (ICD-9-CM Version 2011)
APL
Item
Acute Promyelocytic Leukemia
string
C0023487 (UMLS CUI)
110004001 (SNOMED CT 2010_0731)
10001019 (MedDRA 13.1)
C92.4 (ICD-10-CM Version 2010)
CR
Item
complete remission
string
C0677874 (UMLS CUI)
103338009 (SNOMED CT 2010_0731)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Relapse
Item
Recurrent Disease
string
C0277556 (UMLS CUI)
58184002 (SNOMED CT 2010_0731)
BMT
Item
Bone Marrow Transplantation
string
C0005961 (UMLS CUI)
23719005 (SNOMED CT 2010_0731)
10061730 (MedDRA 13.1)
41.00 (ICD-9-CM Version 2011)
Bone marrow cellularity
Item
Bone Marrow Cellularity Adverse Event
string
C1561532 (UMLS CUI)
Hemoglobin
Item
Hemoglobin
string
C0019046 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Absolute Neutrophil Count
Item
Absolute Neutrophil Count
string
C0948762 (UMLS CUI)
10052033 (MedDRA 13.1)
CML
Item
Chronic myeloid leukemia
string
C0023473 (UMLS CUI)
63364005 (SNOMED CT 2010_0731)
10009700 (MedDRA 13.1)
C92.1 (ICD-10-CM Version 2010)
205.1 (ICD-9-CM Version 2011)
Blast crisis
Item
Blast phase
string
C0005699 (UMLS CUI)
278180008 (SNOMED CT 2010_0731)
10053747 (MedDRA 13.1)
CNS leukemia
Item
Central Nervous System Leukemia
string
C1332884 (UMLS CUI)
10067299 (MedDRA 13.1)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Karnofsky
Item
Karnofsky performance status
string
C0206065 (UMLS CUI)
273546003 (SNOMED CT 2010_0731)
Bilirubin
Item
Bilirubin
string
C0011221 (UMLS CUI)
79706000 (SNOMED CT 2010_0731)
1975-2 (LOINC Version 232)
ALT
Item
GPT
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)
AST
Item
GOT
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
10011358 (MedDRA 13.1)
38483-4 (LOINC Version 232)
Heart Diseases
Item
Cardiac disorder
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)