ID

21406

Description

Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes; ODM derived from: https://clinicaltrials.gov/show/NCT00454480

Link

https://clinicaltrials.gov/show/NCT00454480

Keywords

Versions (1)
  1. 4/19/17 4/19/17 -
Uploaded on

April 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00454480

English

Eligibility Leukemia NCT00454480

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00454480
Criteria
Description

Criteria

diagnosis of 1 of the following:
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0011900
acute myeloid leukemia (aml) meeting the following criteria:
Description

Leukemia, Myelocytic, Acute

Data type

boolean

Alias
UMLS CUI [1]
C0023467
de novo or secondary aml
Description

Acute Myelocytic Leukemia de novo | secondary acute myeloid leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1515568
UMLS CUI [2]
C0280449
no acute promyelocytic leukemia
Description

Acute Promyelocytic Leukemia Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C0332197
high-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
Description

MYELODYSPLASTIC SYNDROME High risk | Bone marrow Blasts Percentage | Refractory anemia with excess blasts II

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C0332167
UMLS CUI [2,1]
C1982687
UMLS CUI [2,2]
C0439165
UMLS CUI [3]
C1318551
no blast transformation of chronic myeloid leukemia
Description

Chronic Myeloid Leukemia Blast transformation Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0023473
UMLS CUI [1,2]
C0024262
UMLS CUI [1,3]
C0332197
patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial mrc-amli5
Description

Age | Unfit Clinical Trial specified

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3841806
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
not pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
ast and alt ≤ 2 times upper limit of normal (uln) (for patients receiving gemtuzumab ozogamicin)
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gemtuzumab ozogamicin

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1533699
bilirubin ≤ 2 times uln (for patients receiving gemtuzumab ozogamicin)
Description

Serum total bilirubin measurement | Gemtuzumab ozogamicin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C1533699
creatinine normal (for patients receiving clofarabine)
Description

Serum creatinine normal | clofarabine

Data type

boolean

Alias
UMLS CUI [1]
C0438244
UMLS CUI [2]
C0092777
no other concurrent active malignancy except basal cell carcinoma
Description

Malignant Neoplasm | Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior cytotoxic chemotherapy for aml
Description

Cytotoxic Chemotherapy Acute Myelocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0023467
hydroxyurea or similar low-dose therapy to control wbc count prior to initiation of intensive therapy allowed
Description

hydroxyurea | Low-Dose Treatment Similar | White Blood Cell Count | Initiation Therapeutic procedure Intensity

Data type

boolean

Alias
UMLS CUI [1]
C0020402
UMLS CUI [2,1]
C1708745
UMLS CUI [2,2]
C2348205
UMLS CUI [3]
C0023508
UMLS CUI [4,1]
C1704686
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0522510
no concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)
Description

Anticonvulsants Enzyme Induction | Phenytoin | Phenobarbital | Primidone | Carbamazepine | oxcarbazepine | tipifarnib

Data type

boolean

Alias
UMLS CUI [1,1]
C0003286
UMLS CUI [1,2]
C0014431
UMLS CUI [2]
C0031507
UMLS CUI [3]
C0031412
UMLS CUI [4]
C0033148
UMLS CUI [5]
C0006949
UMLS CUI [6]
C0069751
UMLS CUI [7]
C1176289
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Similar models

Eligibility Leukemia NCT00454480

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00454480
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Diagnosis
Item
diagnosis of 1 of the following:
boolean
C0011900 (UMLS CUI [1])
Leukemia, Myelocytic, Acute
Item
acute myeloid leukemia (aml) meeting the following criteria:
boolean
C0023467 (UMLS CUI [1])
Acute Myelocytic Leukemia de novo | secondary acute myeloid leukemia
Item
de novo or secondary aml
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0280449 (UMLS CUI [2])
Acute Promyelocytic Leukemia Absent
Item
no acute promyelocytic leukemia
boolean
C0023487 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
MYELODYSPLASTIC SYNDROME High risk | Bone marrow Blasts Percentage | Refractory anemia with excess blasts II
Item
high-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
boolean
C3463824 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C1982687 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1318551 (UMLS CUI [3])
Chronic Myeloid Leukemia Blast transformation Absent
Item
no blast transformation of chronic myeloid leukemia
boolean
C0023473 (UMLS CUI [1,1])
C0024262 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age | Unfit Clinical Trial specified
Item
patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial mrc-amli5
boolean
C0001779 (UMLS CUI [1])
C3841806 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gemtuzumab ozogamicin
Item
ast and alt ≤ 2 times upper limit of normal (uln) (for patients receiving gemtuzumab ozogamicin)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1533699 (UMLS CUI [3])
Serum total bilirubin measurement | Gemtuzumab ozogamicin
Item
bilirubin ≤ 2 times uln (for patients receiving gemtuzumab ozogamicin)
boolean
C1278039 (UMLS CUI [1])
C1533699 (UMLS CUI [2])
Serum creatinine normal | clofarabine
Item
creatinine normal (for patients receiving clofarabine)
boolean
C0438244 (UMLS CUI [1])
C0092777 (UMLS CUI [2])
Malignant Neoplasm | Basal cell carcinoma
Item
no other concurrent active malignancy except basal cell carcinoma
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Cytotoxic Chemotherapy Acute Myelocytic Leukemia
Item
no prior cytotoxic chemotherapy for aml
boolean
C0677881 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
hydroxyurea | Low-Dose Treatment Similar | White Blood Cell Count | Initiation Therapeutic procedure Intensity
Item
hydroxyurea or similar low-dose therapy to control wbc count prior to initiation of intensive therapy allowed
boolean
C0020402 (UMLS CUI [1])
C1708745 (UMLS CUI [2,1])
C2348205 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C1704686 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0522510 (UMLS CUI [4,3])
Anticonvulsants Enzyme Induction | Phenytoin | Phenobarbital | Primidone | Carbamazepine | oxcarbazepine | tipifarnib
Item
no concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)
boolean
C0003286 (UMLS CUI [1,1])
C0014431 (UMLS CUI [1,2])
C0031507 (UMLS CUI [2])
C0031412 (UMLS CUI [3])
C0033148 (UMLS CUI [4])
C0006949 (UMLS CUI [5])
C0069751 (UMLS CUI [6])
C1176289 (UMLS CUI [7])
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