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ID
12799
Beschreibung
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
Stichworte
Versionen (2)
- 21.12.15 21.12.15 -
- 17.09.21 17.09.21 -
Hochgeladen am
21. Dezember 2015
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00957320
Eligibility Acute Lymphoblastic Leukemia NCT00957320
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Acute Lymphoblastic Leukemia NCT00957320
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
C1514463 (UMLS CUI [1,2])
organ function
Item
appropriate organ function.
boolean
C0678852 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
C3548803 (UMLS CUI [2])