ID

12799

Descripción

Study of Sirolimus With PEG-Asparaginase in Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT00957320

Link

https://clinicaltrials.gov/show/NCT00957320

Palabras clave

  1. 21/12/15 21/12/15 -
  2. 17/9/21 17/9/21 -
Subido en

21 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT00957320

Eligibility Acute Lymphoblastic Leukemia NCT00957320

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
less than 21 years old.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
acute lymphoblastic leukemia.
Descripción

all

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023449
second or greater bone marrow relapse or 1st relapse and refractory to at least 2 attempts at re-induction.
Descripción

recurrent disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
life expectancy of at least 8 weeks.
Descripción

life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
fully recovered from the acute toxic effects of all prior therapy.
Descripción

fully recovered from the acute toxic effects

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1546957
UMLS CUI [1,2]
C1514463
appropriate organ function.
Descripción

organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a documented history of ≥ grade 3 local or systemic reactions to peg-asparaginase.
Descripción

allergy to peg-asparaginase

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0071568
patients with a documented history of anti-e. coli asparaginase antibodies.
Descripción

anti-e. coli asparaginase antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003241
UMLS CUI [2]
C0003993
patients with a history of ≥ grade 3 pancreatitis.
Descripción

pancreatitis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030305
patients with an active and uncontrolled infection.
Descripción

infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
patients s/p allogeneic bone marrow transplantation, who are still on immunosuppressants.
Descripción

patients s/p allogeneic bone marrow transplantation, who are still on immunosuppressants

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0085393
UMLS CUI [2]
C0149615
pregnant or lactating females. women of childbearing age will agree to use contraception during the protocol.
Descripción

pregnant or breastfeeding, contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
patients currently receiving other investigational agents, medications, or supplements with a known anti-leukemic effect.
Descripción

study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
other concomitant medications that may alter the metabolism of sirolimus (see section 7.2).
Descripción

other concomitant medications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
patients who, in the opinion of the investigator, will not be able to comply with safety monitoring requirements of the study.
Descripción

patients who, in the opinion of the investigator, will not be able to comply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients with a history of a documented thrombus from previous asparaginase therapy.
Descripción

thrombus from previous asparaginase therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087086
UMLS CUI [2]
C3548803

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00957320

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
less than 21 years old.
boolean
C0001779 (UMLS CUI [1])
all
Item
acute lymphoblastic leukemia.
boolean
C0023449 (UMLS CUI [1])
recurrent disease
Item
second or greater bone marrow relapse or 1st relapse and refractory to at least 2 attempts at re-induction.
boolean
C0277556 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least 8 weeks.
boolean
C0023671 (UMLS CUI [1])
fully recovered from the acute toxic effects
Item
fully recovered from the acute toxic effects of all prior therapy.
boolean
C1546957 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
organ function
Item
appropriate organ function.
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
allergy to peg-asparaginase
Item
patients with a documented history of ≥ grade 3 local or systemic reactions to peg-asparaginase.
boolean
C0020517 (UMLS CUI [1])
C0071568 (UMLS CUI [2])
anti-e. coli asparaginase antibodies
Item
patients with a documented history of anti-e. coli asparaginase antibodies.
boolean
C0003241 (UMLS CUI [1])
C0003993 (UMLS CUI [2])
pancreatitis
Item
patients with a history of ≥ grade 3 pancreatitis.
boolean
C0030305 (UMLS CUI [1])
infection
Item
patients with an active and uncontrolled infection.
boolean
C0009450 (UMLS CUI [1])
patients s/p allogeneic bone marrow transplantation, who are still on immunosuppressants
Item
patients s/p allogeneic bone marrow transplantation, who are still on immunosuppressants.
boolean
C0085393 (UMLS CUI [1])
C0149615 (UMLS CUI [2])
pregnant or breastfeeding, contraception
Item
pregnant or lactating females. women of childbearing age will agree to use contraception during the protocol.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
study subject participation status
Item
patients currently receiving other investigational agents, medications, or supplements with a known anti-leukemic effect.
boolean
C2348568 (UMLS CUI [1])
other concomitant medications
Item
other concomitant medications that may alter the metabolism of sirolimus (see section 7.2).
boolean
C2347852 (UMLS CUI [1])
patients who, in the opinion of the investigator, will not be able to comply
Item
patients who, in the opinion of the investigator, will not be able to comply with safety monitoring requirements of the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
thrombus from previous asparaginase therapy
Item
patients with a history of a documented thrombus from previous asparaginase therapy.
boolean
C0087086 (UMLS CUI [1])
C3548803 (UMLS CUI [2])

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