Acute Myelocytic Leukemia refractory | Acute Myelocytic Leukemia Relapsed | Acute lymphocytic leukaemia refractory | Acute lymphocytic leukemia Relapsed | MYELODYSPLASTIC SYNDROME refractory | MYELODYSPLASTIC SYNDROME Relapsed | Chronic Lymphocytic Leukemia | fludarabine failed | Myeloid Leukemia, Chronic | Resistance Hematologic Imatinib mesylate | Cytogenetic No Response Imatinib mesylate
Item
1. for phase i component of the study: patients with refractory or relapsed: acute myelogenous leukemia (aml), acute lymphocytic leukemia (all), and myelodysplastic syndrome (mds) are eligible. patients with chronic lymphocytic leukemia (cll) are eligible if fludarabine based therapy has failed. patients with chronic myeloid leukemia (cml) are eligible if they have documented hematologic resistance to imatinib mesylate or have not achieved or lost any cytogenetic response to imatinib mesylate after 12 months of therapy.
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0205336 (UMLS CUI [2,2])
C4049242 (UMLS CUI [3])
C0023449 (UMLS CUI [4,1])
C0205336 (UMLS CUI [4,2])
C3463824 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C3463824 (UMLS CUI [6,1])
C0205336 (UMLS CUI [6,2])
C0023434 (UMLS CUI [7])
C0059985 (UMLS CUI [8,1])
C0231175 (UMLS CUI [8,2])
C0023473 (UMLS CUI [9])
C1514892 (UMLS CUI [10,1])
C0205488 (UMLS CUI [10,2])
C0939537 (UMLS CUI [10,3])
C4055170 (UMLS CUI [11,1])
C0939537 (UMLS CUI [11,2])
Patients untreated | Age | Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME | Chemotherapy Primary Refused | Chemotherapy Primary Ineligible
Item
2. untreated patients older than 60 years of age with aml or mds who refuse or are not eligible for frontline chemotherapy, are eligible.
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C3463824 (UMLS CUI [4])
C3665472 (UMLS CUI [5,1])
C0205225 (UMLS CUI [5,2])
C1705116 (UMLS CUI [5,3])
C3665472 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C1512714 (UMLS CUI [6,3])
ECOG performance status
Item
3. performance status of =/< 2 by the ecog scale.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
4. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of utmdacc.
boolean
C0021430 (UMLS CUI [1])
Age
Item
5. age > 2 years.
boolean
C0001779 (UMLS CUI [1])
Chemotherapy To be stopped | Toxic effect Due to Chemotherapy | Patient Recovered | Rapidly progressive disorder Evidence of | hydroxyurea | Disease Proliferative Rapid | Imatinib mesylate | Gleevec | anagrelide
Item
6. patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy. imatinib mesylate (gleevec) and anagrelide must also be stopped 2 weeks prior to entering this study.
boolean
C3665472 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C3665472 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
C1850776 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
C0020402 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C0334094 (UMLS CUI [6,2])
C0456962 (UMLS CUI [6,3])
C0939537 (UMLS CUI [7])
C0935987 (UMLS CUI [8])
C0051809 (UMLS CUI [9])
Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
7. adequate liver function (bilirubin of < 2mg%, sgpt < 3 x uln) and renal function (creatinine < 2mg%).
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
8. women of childbearing potential must practice contraception. men and women must continue birth control for the duration of the trial.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Leukemia, Myelocytic, Acute | MYELODYSPLASTIC SYNDROME High risk of | Blast count procedure | Patients untreated | Age | Chemotherapy Primary Refused | Chemotherapy Primary Ineligible
Item
9. inclusion of phase ii portion of the study: as in the phase i portion but only patients with aml or high-risk mds (blasts > or = 10%), including untreated patients older than 60 years of age with aml or mds who refuse or are not eligible for frontline chemotherapy, will be eligible in this portion of the study.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C0523113 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0001779 (UMLS CUI [5])
C3665472 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C1705116 (UMLS CUI [6,3])
C3665472 (UMLS CUI [7,1])
C0205225 (UMLS CUI [7,2])
C1512714 (UMLS CUI [7,3])
Breast Feeding | Pregnancy
Item
1. nursing and pregnant females are excluded.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Communicable Diseases | Communicable Diseases Uncontrolled
Item
2. patients with active and uncontrolled infections are excluded.
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Ornithine carbamoyltransferase deficiency | Coma Cause Unknown | Ornithine carbamoyltransferase deficiency Family history
Item
3. patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study.
boolean
C0268542 (UMLS CUI [1])
C0009421 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
C0268542 (UMLS CUI [3,1])
C0241889 (UMLS CUI [3,2])
Illness Uncontrolled Protocol Compliance Limited | Symptomatic congestive heart failure | Angina, Unstable | Pancreatitis | Mental disorders
Item
4. uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, pancreatitis, psychiatric illness that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0742758 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
Hepatitis B | Hepatitis C | Alcoholic Liver Diseases | Liver disease Evidence of
Item
5. patients with history of hepatitis b, c, alcoholic liver disease or evidence of hepatopathy will be excluded.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0023896 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
Valproic Acid | Anticonvulsants
Item
6. patients already receiving valproic acid or receiving other anticonvulsivants will be excluded.
boolean
C0042291 (UMLS CUI [1])
C0003286 (UMLS CUI [2])
Age | Patients untreated
Item
7. untreated patients younger than 60 years will not be candidates for this study.
boolean
C0001779 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])