ID

30175

Description

S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00551460

Link

https://clinicaltrials.gov/show/NCT00551460

Keywords

Versions (1)
  1. 5/16/18 5/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00551460

English

Eligibility Leukemia NCT00551460

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00551460
Criteria
Description

Criteria

morphologically confirmed acute promyelocytic leukemia (apl) based on bone marrow examination
Description

Acute Promyelocytic Leukemia Bone Marrow Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0023487
UMLS CUI [1,2]
C0005957
apl-rarα-negative by rt-pcr are not eligible
Description

Exclusion Other Coding RT PCR

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C3846158
UMLS CUI [1,3]
C0599161
high-risk disease, defined as wbc > 100,000/mm^3
Description

Disease High risk | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332167
UMLS CUI [2]
C0023508
bone marrow specimens must be made available for cytogenetic studies
Description

Bone marrow specimen Available Cytogenetic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0438737
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0200896
patient characteristics:
Description

Client Characteristics

Data type

boolean

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

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
fertile patients must use effective contraception
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no prolonged qtc > 0.47 sec
Description

Exclusion Prolonged QTc

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1969409
no other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or stage ii cancer from which the patients is currently in complete remission
Description

Exclusion Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Treated TNM clinical staging | Exception Malignant Neoplasms In complete remission

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C1522326
UMLS CUI [5,4]
C3258246
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0006826
UMLS CUI [6,3]
C0677874
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior systemic chemotherapy for acute leukemia
Description

Exclusion Systemic Chemotherapy Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C1883256
UMLS CUI [1,3]
C0023418
at least 3 days since prior tretinoin (atra) allowed
Description

Tretinoin Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0040845
UMLS CUI [1,2]
C0205156
prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
Description

Hydroxyurea Previous | Adrenal Cortex Hormones Previous | Leukapheresis Previous | Control Cell Count High

Data type

boolean

Alias
UMLS CUI [1,1]
C0020402
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C0023416
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0243148
UMLS CUI [4,2]
C0007584
UMLS CUI [4,3]
C0205250
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Similar models

Eligibility Leukemia NCT00551460

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00551460
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Acute Promyelocytic Leukemia Bone Marrow Examination
Item
morphologically confirmed acute promyelocytic leukemia (apl) based on bone marrow examination
boolean
C0023487 (UMLS CUI [1,1])
C0005957 (UMLS CUI [1,2])
Exclusion Other Coding RT PCR
Item
apl-rarα-negative by rt-pcr are not eligible
boolean
C2828389 (UMLS CUI [1,1])
C3846158 (UMLS CUI [1,2])
C0599161 (UMLS CUI [1,3])
Disease High risk | White Blood Cell Count procedure
Item
high-risk disease, defined as wbc > 100,000/mm^3
boolean
C0012634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
Bone marrow specimen Available Cytogenetic procedure
Item
bone marrow specimens must be made available for cytogenetic studies
boolean
C0438737 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0200896 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Prolonged QTc
Item
no prolonged qtc > 0.47 sec
boolean
C2828389 (UMLS CUI [1,1])
C1969409 (UMLS CUI [1,2])
Exclusion Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Malignant Neoplasms Treated TNM clinical staging | Exception Malignant Neoplasms In complete remission
Item
no other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or stage ii cancer from which the patients is currently in complete remission
boolean
C2828389 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C3258246 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0677874 (UMLS CUI [6,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion Systemic Chemotherapy Leukemia
Item
no prior systemic chemotherapy for acute leukemia
boolean
C2828389 (UMLS CUI [1,1])
C1883256 (UMLS CUI [1,2])
C0023418 (UMLS CUI [1,3])
Tretinoin Previous
Item
at least 3 days since prior tretinoin (atra) allowed
boolean
C0040845 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Hydroxyurea Previous | Adrenal Cortex Hormones Previous | Leukapheresis Previous | Control Cell Count High
Item
prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts allowed
boolean
C0020402 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0023416 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0243148 (UMLS CUI [4,1])
C0007584 (UMLS CUI [4,2])
C0205250 (UMLS CUI [4,3])
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