ID

41130

Beskrivning

BI 836858 Dose Escalation in Refractory or Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01690624

Länk

https://clinicaltrials.gov/show/NCT01690624

Nyckelord

Versioner (1)
  1. 2020-06-28 2020-06-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT01690624

Engelsk

Eligibility Leukemia, Myeloid, Acute NCT01690624

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of relapsed or refractory aml with at least one prior treatment for acute myeloid leukemia.
Beskrivning

Recurrent Acute Myeloid Leukemia | Acute lymphocytic leukemia refractory | Prior Therapy Quantity AML

Datatyp

boolean

Alias
UMLS CUI [1]
C1142169
UMLS CUI [2]
C4049242
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0023467
2. expression of cd33 on more than 30% of bone marrow blasts.
Beskrivning

CD33 Expression | Blast cells in bone marrow Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1439292
UMLS CUI [1,2]
C0017262
UMLS CUI [2,1]
C4539635
UMLS CUI [2,2]
C0439165
3. eastern cooperative oncology group performance status 0, 1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. written informed consent which is consistent with international conference on harmonization ¿ good clinical practice (ich-gcp) guidelines and local legislation.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with acute promyelocytic leukemia according to who definition.
Beskrivning

Acute Promyelocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
2. patients with > 5.000 leukocytes/µl in the peripheral blood
Beskrivning

White Blood Cell Count Peripheral blood

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0229664
3. anti-leukemia therapy within two weeks before first treatment with bi 836858, 4 weeks for biologics
Beskrivning

Therapy Against Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0023418
4. allogeneic stem cell transplantation within the last 3 months or with evidence of graft versus host disease
Beskrivning

Allogeneic hematopoietic stem cell transplant | Graft-vs-Host Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C4255274
UMLS CUI [2]
C0018133
5. patients who are candidates for allogeneic stem cell transplantation.
Beskrivning

Patients Appropriate Allogeneic hematopoietic stem cell transplant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C4255274
6. second malignancy currently requiring active therapy.
Beskrivning

Secondary Malignant Neoplasm Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C0332121
7. symptomatic central nervous system involvement
Beskrivning

Central Nervous System Involvement Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0231220
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.
Beskrivning

Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased | Gilbert Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0017551
9. prothrombin time (pt) >1.5 x uln for subjects not on therapeutic vitamin k antagonists (phenprocoumon, warfarin)
Beskrivning

Prothrombin time increased | Vitamin K antagonists Absent | Phenprocoumon Absent | Warfarin Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0151872
UMLS CUI [2,1]
C3653316
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0031444
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0043031
UMLS CUI [4,2]
C0332197
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.
Beskrivning

Serum total bilirubin measurement | Exception Due to Leukemic infiltration hepatic | Exception Due to Gilbert Disease | Exception Due to Hemolysis

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1142074
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0017551
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0019054
11. serum creatinine greater than 2.0 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
12. known human immunodeficiency virus (hiv) infection or active hepatitis b virus or hepatitis c virus infection.
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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
Beskrivning

Comorbidity At risk Study Subject Participation Status | Condition At risk Study Subject Participation Status | Communicable Disease Severe | Angina, Unstable | New onset Exacerbation Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0746890
UMLS CUI [5,2]
C4086268
UMLS CUI [5,3]
C0003811
14. psychiatric illness or social situation that would limit compliance with trial requirements
Beskrivning

Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
15. concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
Beskrivning

Therapy concomitant | Relevance Evaluation Investigational New Drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C0013230
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
Beskrivning

|

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
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
Beskrivning

Gender Partner Childbearing Potential | Barrier Contraception Double Unwilling | Use of Condoms Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0009653
UMLS CUI [3,3]
C0558080
18. pregnant or nursing female patients
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
19. treatment with another investigational agent under the following conditions:
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
1. within two weeks (4 weeks for biologics) of first administration of bi 836858; or
Beskrivning

Administration Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0332185
2. patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the investigator.
Beskrivning

Toxicity Due to Prior Therapy | Prior Therapy Against Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0023418
3. concomitant treatment with another investigational agent while participating in this trial.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
20. prior treatment with a cd33 antibody
Beskrivning

CD33 Antibodies

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1439292
UMLS CUI [1,2]
C0003241
21. patient unable or unwilling to comply with the protocol.
Beskrivning

Protocol Compliance Unable | Protocol Compliance Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT01690624

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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