Acute leukemia Recurrent | Acute leukemia Refractory | MYELODYSPLASTIC SYNDROME High risk | Standard therapy Unsuccessful | Disease remission Unlikely
Item
1. patients must have relapsed or refractory acute leukemias or high-risk mds for which no standard therapies are anticipated to result in a durable remission.
boolean
C0085669 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0085669 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C4319571 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0544452 (UMLS CUI [5,1])
C0750558 (UMLS CUI [5,2])
Age
Item
2. age >/=18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization Absent | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | CERVICAL CAP FOR CONTRACEPTIVE USE | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Breast Feeding Excluded | Gender Sexually active Contraceptive methods | Pregnancy Excluded
Item
4. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [iud], oral contraceptive or double barrier device, such as a condom, diaphragm, or cervical/vault cap), for 16 weeks after the last dose of study drug, and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. nursing patients are excluded. sexually active men must also use acceptable contraceptive methods for the duration of time on study and for at least 16 weeks after the last dose of study drug. pregnant and nursing patients are excluded because the effects of onc201on a fetus or nursing child are unknown.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2])
C0015787 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C0004764 (UMLS CUI [7,1])
C0205173 (UMLS CUI [7,2])
C0221829 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0493327 (UMLS CUI [10])
C3831118 (UMLS CUI [11,1])
C0430061 (UMLS CUI [11,2])
C3831118 (UMLS CUI [12,1])
C0430057 (UMLS CUI [12,2])
C0006147 (UMLS CUI [13,1])
C0332196 (UMLS CUI [13,2])
C0079399 (UMLS CUI [14,1])
C0241028 (UMLS CUI [14,2])
C0700589 (UMLS CUI [14,3])
C0032961 (UMLS CUI [15,1])
C0332196 (UMLS CUI [15,2])
Informed Consent
Item
5. must be able and willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Cytotoxic agent | Pharmaceutical Preparations Except Cytotoxic agent | hydroxyurea | Blood Cell Count Peripheral Leukemic | Prior Therapy Toxicity CTCAE Grades
Item
6. the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. persistent clinically significant toxicities from prior therapy must not be greater than grade 1.
boolean
C0304497 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0304497 (UMLS CUI [2,3])
C0020402 (UMLS CUI [3])
C0005771 (UMLS CUI [4,1])
C0229664 (UMLS CUI [4,2])
C1517806 (UMLS CUI [4,3])
C1514463 (UMLS CUI [5,1])
C0600688 (UMLS CUI [5,2])
C1516728 (UMLS CUI [5,3])
Laboratory Results Required | Exception Involvement with Leukemia | Creatinine measurement, serum | Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Exception Involvement with Leukemia
Item
7. patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: (1) serum creatinine < 2.0 mg/dl; (2) total bilirubin </= 1.5 x the upper limit of normal (uln) unless considered due to gilbert's syndrome; (3) alanine aminotransferase (alt), or aspartate aminotransferase (ast) </= 3 x the uln unless considered due to organ leukemic involvement.
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0017551 (UMLS CUI [5,2])
C0201836 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1314939 (UMLS CUI [8,2])
C0023418 (UMLS CUI [8,3])
CNS disorder | Imaging Negative | Spinal Fluid Analysis Negative
Item
8. patients with known central nervous system (cns) disease are allowed if there is no evidence of active cns disease as documented by negative imaging or spinal fluid analysis carried out at least 2 weeks prior to study drug administration. information obtained from standard of care historical data will be used for this purpose.
boolean
C0007682 (UMLS CUI [1])
C0011923 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0007806 (UMLS CUI [3,1])
C0002778 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell | Status post Allogeneic Stem Cell Transplantation | Graft-vs-Host Disease Grade Absent | Absence Steroids High dose Graft-vs-Host Disease | Prednisolone Dose U/day | Equivalent | Immunosuppressive Agents Absent | Exception Cyclosporine Low dose | Exception Tacrolimus Low dose
Item
9. relapse > 6 months since autologous or allogeneic stem cell transplantation provided: (1) no active graft-versus-host disease (gvhd > grade 1); (2) no treatment with high dose steroids for gvhd (up to >/= 20 mg prednisolone or equivalent per day); (3) no treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus.
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1831743 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C2242529 (UMLS CUI [3,2])
C0018133 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0038317 (UMLS CUI [5,2])
C0444956 (UMLS CUI [5,3])
C0018133 (UMLS CUI [5,4])
C0032950 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0456683 (UMLS CUI [6,3])
C0205163 (UMLS CUI [7])
C0021081 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0010592 (UMLS CUI [9,2])
C0445550 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0085149 (UMLS CUI [10,2])
C0445550 (UMLS CUI [10,3])
Comorbidity Uncontrolled | Communicable Disease Uncontrolled | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
1. uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (new york heart association class iii and iv), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0004936 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Heart Disease | Myocardial Infarction | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Uncontrolled | Congestive heart failure Uncontrolled New York Heart Association Classification
Item
2. active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure (new york heart association class iii and iv).
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C1275491 (UMLS CUI [5,3])
Standard therapy Hematologic Neoplasms | Investigational Therapy Hematologic Neoplasms | Cytotoxic agent | Pharmaceutical Preparations Except Cytotoxic agent
Item
3. patients receiving any other standard or investigational treatment for their hematologic malignancy within past 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents.
boolean
C2936643 (UMLS CUI [1,1])
C0376545 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0376545 (UMLS CUI [2,2])
C0304497 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0304497 (UMLS CUI [4,3])
Cancer Other | Cancer Other Treated | Exception Carcinoma in Situ | Exception Prostate carcinoma Low Risk | Exception Skin carcinoma Low Risk | Exception Cervix carcinoma Low Risk | Status post Curative treatment
Item
4. subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
boolean
C1707251 (UMLS CUI [1])
C1707251 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C3538919 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C3538919 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0302592 (UMLS CUI [6,2])
C3538919 (UMLS CUI [6,3])
C0231290 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
Seropositive Human immunodeficiency virus type 1 antibody | Seropositive Human immunodeficiency virus type II antibody | Seropositive Hepatitis C Antibodies | Hepatitis B carrier | Hepatitis B surface antigen positive
Item
5. known history of seropositive for human immunodeficiency virus (hiv) antibodies (hiv1 and hiv2), hepatitis c antibody (hep c ab) or a hepatitis b carrier (positive for hepatitis b surface antigen [hbsag])
boolean
C0521143 (UMLS CUI [1,1])
C0369497 (UMLS CUI [1,2])
C0521143 (UMLS CUI [2,1])
C0369500 (UMLS CUI [2,2])
C0521143 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
C0262505 (UMLS CUI [4])
C0149709 (UMLS CUI [5])
Drug Use Disorders | Alcoholic Intoxication, Chronic
Item
6. active drug use or alcoholism.
boolean
C0013222 (UMLS CUI [1])
C0001973 (UMLS CUI [2])