ID

13704

Description

A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00620321

Link

https://clinicaltrials.gov/show/NCT00620321

Keywords

Versions (1)
  1. 2/29/16 2/29/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 29, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00620321

English

Eligibility Acute Myeloid Leukemia NCT00620321

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to a least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (cml) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (tk1). a baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug.
Description

patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to a least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (cml) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (tk1). a baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug.

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0277556
UMLS CUI [2]
C1531552
must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration. administration.
Description

must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration. administration.

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C1444662
UMLS CUI [5,1]
C0949266
UMLS CUI [5,2]
C1444662
UMLS CUI [6]
C2004454
UMLS CUI [7]
C0020402
must have adequate organ function.
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
females must have a negative pregnancy test. male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
Description

pregnancy test and contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0700589
patients must be at least 18 years old.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
Description

have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.

Data type

boolean

Alias
UMLS CUI [1]
C1514463
patients with acute promyelocytic leukemia (apml).
Description

patients with acute promyelocytic leukemia (apml).

Data type

boolean

Alias
UMLS CUI [1]
C0023487
major surgery within 4 weeks of study enrollment.
Description

major surgery within 4 weeks of study enrollment.

Data type

boolean

Alias
UMLS CUI [1]
C0679637
patients with serious pre-existing medical conditions (at the discretion of the investigator). because of the known cardiac toxicity of anthra- cyclines, patients with pre-existing ejection fraction (ef) less than or equal to 45% should not participate in this study. no patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120mg/m2).
Description

patients with serious pre-existing medical conditions (at the discretion of the investigator). because of the known cardiac toxicity of anthra- cyclines, patients with pre-existing ejection fraction (ef) less than or equal to 45% should not participate in this study. no patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120mg/m2).

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0232174
UMLS CUI [3]
C0282564
patients with a second malignancy that could affect the interpretation of the results.
Description

patients with a second malignancy that could affect the interpretation of the results.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients with leukemic involvement of the cns by spinal fluid cytology or imaging.
Description

patients with leukemic involvement of the cns by spinal fluid cytology or imaging.

Data type

boolean

Alias
UMLS CUI [1]
C1332884
patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.
Description

patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.

Data type

boolean

Alias
UMLS CUI [1]
C0005779
concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).
Description

concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).

Data type

boolean

Alias
UMLS CUI [1]
C0150457
women who are pregnant or breast feeding.
Description

women who are pregnant or breast feeding.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.
Description

patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.

Data type

boolean

Alias
UMLS CUI [1,1]
C0028953
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0020789
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C0010711
UMLS CUI [3,2]
C0020517
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Similar models

Eligibility Acute Myeloid Leukemia NCT00620321

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML or CML
Item
patients who have a diagnosis of acute myeloid leukemia that is relapsed or refractory to a least 1 prior treatment for leukemia, or patients with chronic myeloid leukemia (cml) who are in myeloid blast crisis which have failed at least 1 previous tyrosine kinase inhibitor (tk1). a baseline bone marrow assessment is required less than or equal to 96 hours prior to the first dose of study drug.
boolean
C0023467 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1531552 (UMLS CUI [2])
discontinuation of all previous therapies for cancer
Item
must have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, cancer related hormone therapy, or other investigational therapy for at least 21 days for myelosuppressive agents (such as cytarabine, daunorubicin, and gemtuzumab ozogamicin) or 14 days for non-myelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (such as neurotoxicity, diarrhea, and mucositis) except for residual myelosuppression and alopecia. hydroxyurea is permitted to control the peripheral blast cell count, but must be stopped at least 24 hours before study drug administration. administration.
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C0949266 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C2004454 (UMLS CUI [6])
C0020402 (UMLS CUI [7])
organ function
Item
must have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
pregnancy test and contraception
Item
females must have a negative pregnancy test. male and female patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
age
Item
patients must be at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior therapy
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
boolean
C1514463 (UMLS CUI [1])
APML
Item
patients with acute promyelocytic leukemia (apml).
boolean
C0023487 (UMLS CUI [1])
major surgery
Item
major surgery within 4 weeks of study enrollment.
boolean
C0679637 (UMLS CUI [1])
serious pre-existing medical conditions
Item
patients with serious pre-existing medical conditions (at the discretion of the investigator). because of the known cardiac toxicity of anthra- cyclines, patients with pre-existing ejection fraction (ef) less than or equal to 45% should not participate in this study. no patient should exceed the maximum exposure of anthracycline doses (for example, idarubicin greater than 120mg/m2).
boolean
C0009488 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
C0282564 (UMLS CUI [3])
malignancy
Item
patients with a second malignancy that could affect the interpretation of the results.
boolean
C0006826 (UMLS CUI [1])
cns leukemia
Item
patients with leukemic involvement of the cns by spinal fluid cytology or imaging.
boolean
C1332884 (UMLS CUI [1])
coagulopathy or bleeding disorder
Item
patients with known coagulopathy or bleeding disorder, other than leukemia related thrombocytopenia. patients with severe of life threatening bleeding refractory to platelet transfusions are also excluded.
boolean
C0005779 (UMLS CUI [1])
anticoagulant therapy
Item
concomitant anticoagulant therapy (with the exception of heparinized saline to maintain the patency of central venous catheters).
boolean
C0150457 (UMLS CUI [1])
pregnancy or breast feeding
Item
women who are pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hypersensitivity
Item
patients with a known hypersensitivity to oligonucleotides, idarubicin, and/or cytarabine.
boolean
C0028953 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020789 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0010711 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
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