ID

12799

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00957320

Nyckelord

  1. 2015-12-21 2015-12-21 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

21 december 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT00957320

Eligibility Acute Lymphoblastic Leukemia NCT00957320

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
less than 21 years old.
Beskrivning

age

Datatyp

boolean

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

all

Datatyp

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.
Beskrivning

recurrent disease

Datatyp

boolean

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

life expectancy

Datatyp

boolean

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

fully recovered from the acute toxic effects

Datatyp

boolean

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

organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

allergy to peg-asparaginase

Datatyp

boolean

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

anti-e. coli asparaginase antibodies

Datatyp

boolean

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

pancreatitis

Datatyp

boolean

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

infection

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

pregnant or breastfeeding, contraception

Datatyp

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.
Beskrivning

study subject participation status

Datatyp

boolean

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

other concomitant medications

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

thrombus from previous asparaginase therapy

Datatyp

boolean

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

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00957320

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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