ID

13707

Description

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00703820

Link

https://clinicaltrials.gov/show/NCT00703820

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 NCT00703820

English

Eligibility Acute Myeloid Leukemia NCT00703820

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age less than or equal to 21 years at time of study entry.
Description

age less than or equal to 21 years at time of study entry.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis.
Description

no prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis.

Data type

boolean

Alias
UMLS CUI [1]
C1514463
written informed consent according to institutional guidelines
Description

written informed consent according to institutional guidelines

Data type

boolean

Alias
UMLS CUI [1]
C0021430
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
Description

female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment

Data type

boolean

Alias
UMLS CUI [1]
C0032976
male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Description

male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
down syndrome
Description

down syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0013080
acute promyelocytic leukemia (apl)
Description

acute promyelocytic leukemia (apl)

Data type

boolean

Alias
UMLS CUI [1]
C0023487
juvenile myelomonocytic leukemia (jmml)
Description

juvenile myelomonocytic leukemia (jmml)

Data type

boolean

Alias
UMLS CUI [1]
C0349639
fanconi anemia (fa)
Description

fanconi anemia (fa)

Data type

boolean

Alias
UMLS CUI [1]
C0015625
kostmann syndrome
Description

kostmann syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1853118
shwachman syndrome
Description

shwachman syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0272170
other bone marrow failure syndromes
Description

other bone marrow failure syndromes

Data type

boolean

Alias
UMLS CUI [1]
C2931245
use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Description

use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C1531518
use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of it therapy, hydroxyurea, or low-dose cytarabine as stated above. the patient must have recovered from all acute toxicities from any previous therapy.
Description

use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of it therapy, hydroxyurea, or low-dose cytarabine as stated above. the patient must have recovered from all acute toxicities from any previous therapy.

Data type

boolean

Alias
UMLS CUI [1]
C1875319
systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Description

systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pregnant or lactating patients.
Description

pregnant or lactating patients.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Description

any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Acute Myeloid Leukemia NCT00703820

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age less than or equal to 21 years at time of study entry.
boolean
C0001779 (UMLS CUI [1])
prior therapy
Item
no prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis.
boolean
C1514463 (UMLS CUI [1])
written informed consent
Item
written informed consent according to institutional guidelines
boolean
C0021430 (UMLS CUI [1])
pregnancy test
Item
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
boolean
C0032976 (UMLS CUI [1])
contraception
Item
male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
down syndrome
Item
down syndrome
boolean
C0013080 (UMLS CUI [1])
apl
Item
acute promyelocytic leukemia (apl)
boolean
C0023487 (UMLS CUI [1])
juvenile myelomonocytic leukemia
Item
juvenile myelomonocytic leukemia (jmml)
boolean
C0349639 (UMLS CUI [1])
fanconi anemia
Item
fanconi anemia (fa)
boolean
C0015625 (UMLS CUI [1])
kostmann syndrome
Item
kostmann syndrome
boolean
C1853118 (UMLS CUI [1])
shwachman syndrome
Item
shwachman syndrome
boolean
C0272170 (UMLS CUI [1])
bone marrow failure syndromes
Item
other bone marrow failure syndromes
boolean
C2931245 (UMLS CUI [1])
use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Item
use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
use of investigational agents
Item
use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of it therapy, hydroxyurea, or low-dose cytarabine as stated above. the patient must have recovered from all acute toxicities from any previous therapy.
boolean
C1875319 (UMLS CUI [1])
systemic infection
Item
systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
boolean
C0009488 (UMLS CUI [1])
pregnancy or lactation
Item
pregnant or lactating patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
comorbidity interfering with study protocol
Item
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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