Recurrent Acute Myeloid Leukemia | Acute lymphocytic leukemia refractory | Prior Therapy Quantity AML
Item
1. diagnosis of relapsed or refractory aml with at least one prior treatment for acute myeloid leukemia.
boolean
C1142169 (UMLS CUI [1])
C4049242 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0023467 (UMLS CUI [3,3])
CD33 Expression | Blast cells in bone marrow Percentage
Item
2. expression of cd33 on more than 30% of bone marrow blasts.
boolean
C1439292 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C4539635 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
ECOG performance status
Item
3. eastern cooperative oncology group performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
4. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
5. written informed consent which is consistent with international conference on harmonization ¿ good clinical practice (ich-gcp) guidelines and local legislation.
boolean
C0021430 (UMLS CUI [1])
Acute Promyelocytic Leukemia
Item
1. patients with acute promyelocytic leukemia according to who definition.
boolean
C0023487 (UMLS CUI [1])
White Blood Cell Count Peripheral blood
Item
2. patients with > 5.000 leukocytes/µl in the peripheral blood
boolean
C0023508 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Therapy Against Leukemia
Item
3. anti-leukemia therapy within two weeks before first treatment with bi 836858, 4 weeks for biologics
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0023418 (UMLS CUI [1,3])
Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease
Item
4. allogeneic stem cell transplantation within the last 3 months or with evidence of graft versus host disease
boolean
C4255274 (UMLS CUI [1])
C0018133 (UMLS CUI [2])
Patients Appropriate Allogeneic hematopoietic stem cell transplant
Item
5. patients who are candidates for allogeneic stem cell transplantation.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C4255274 (UMLS CUI [1,3])
Secondary Malignant Neoplasm Treatment required for
Item
6. second malignancy currently requiring active therapy.
boolean
C3266877 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Central Nervous System Involvement Symptomatic
Item
7. symptomatic central nervous system involvement
boolean
C4050309 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased | Gilbert Disease
Item
8. aspartate amino transferase (ast) or alanine amino transferase (alt) greater than 2.5 times the upper limit of normal (uln), or ast or alt greater than 5 times the uln for those with gilbert syndrome.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0017551 (UMLS CUI [3])
Prothrombin time increased | Vitamin K antagonists Absent | Phenprocoumon Absent | Warfarin Absent
Item
9. prothrombin time (pt) >1.5 x uln for subjects not on therapeutic vitamin k antagonists (phenprocoumon, warfarin)
boolean
C0151872 (UMLS CUI [1])
C3653316 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0031444 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0043031 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Serum total bilirubin measurement | Exception Due to Leukemic infiltration hepatic | Exception Due to Gilbert Disease | Exception Due to Hemolysis
Item
10. bilirubin greater than 1.5 mg/dl (>26 µmol/l) unless elevation is thought to be due to hepatic infiltration by aml, gilbert syndrome, or hemolysis.
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1142074 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0017551 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0019054 (UMLS CUI [4,3])
Creatinine measurement, serum
Item
11. serum creatinine greater than 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C
Item
12. known human immunodeficiency virus (hiv) infection or active hepatitis b virus or hepatitis c virus infection.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Comorbidity At risk Study Subject Participation Status | Condition At risk Study Subject Participation Status | Communicable Disease Severe | Angina, Unstable | New onset Exacerbation Cardiac Arrhythmia
Item
13. concomitant intercurrent illness, or any condition which in the opinion of the investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0746890 (UMLS CUI [5,1])
C4086268 (UMLS CUI [5,2])
C0003811 (UMLS CUI [5,3])
Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
14. psychiatric illness or social situation that would limit compliance with trial requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Therapy concomitant | Relevance Evaluation Investigational New Drug
Item
15. concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
boolean
C0087111 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C2347946 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Childbearing Potential Sexually active | Contraceptive methods Unwilling
Item
16. female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial and for 6 months after the last administration of bi 836858
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Gender Partner Childbearing Potential | Barrier Contraception Double Unwilling | Use of Condoms Unwilling
Item
17. male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second effective method of contraception during the trial and for 6 months after the last administration of bi 836858
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0009653 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
18. pregnant or nursing female patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
19. treatment with another investigational agent under the following conditions:
boolean
C0013230 (UMLS CUI [1])
Administration Recent
Item
1. within two weeks (4 weeks for biologics) of first administration of bi 836858; or
boolean
C1533734 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Toxicity Due to Prior Therapy | Prior Therapy Against Leukemia
Item
2. patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the investigator.
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0023418 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
3. concomitant treatment with another investigational agent while participating in this trial.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
CD33 Antibodies
Item
20. prior treatment with a cd33 antibody
boolean
C1439292 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
21. patient unable or unwilling to comply with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])