ID

12768

Description

Trial of Sirolimus and Methotrexate in Relapsed/Refractory Lymphoblastic Leukemia and Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01162551

Link

https://clinicaltrials.gov/show/NCT01162551

Keywords

Versions (1)
  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Cancer NCT01162551

English

Eligibility Cancer NCT01162551

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01162551
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients </= 25 years of age, at time of enrollment, with second or greater relapse of all or nhl. for all must have histologic diagnosis with >10% blasts in the marrow and for lymphoblastic lymphoma or peripheral t-cell lymphoma must have radiologic or physical evidence of recurrence.
Description

age; Acute lymphocytic leukemia; recurrence

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023449
UMLS CUI [3]
C0034897
lansky > 50% or karnofsky > 50%
Description

Lansky Play-Performance Status; Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1522275
UMLS CUI [2]
C0206065
negative pregnancy test
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
creatinine clearance or radioisotope gfr > 70ml/min/m2 or serum creatinine based on age /gender
Description

creatinine clearance; age; gender

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
pulse ox >94%
Description

pulse oximetry

Data type

boolean

Alias
UMLS CUI [1]
C0034108
total bilirubin <1.5 x normal for age
Description

total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
alt < 5 x normal for age
Description

Alanine Transaminase

Data type

boolean

Alias
UMLS CUI [1]
C1557189
albumin > 2g/dl
Description

albumin

Data type

boolean

Alias
UMLS CUI [1]
C0201838
shortening fraction by echo > 28% or ejection fraction > 50% by gated radionuclide study
Description

ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0489482
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has known allergies to sirolimus,fk-506 or mtor inhibitors
Description

hypersensitivity sirolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0072980
patient is taking other investigational anti-neoplastic drugs
Description

investigational anti-neoplastic drugs other

Data type

boolean

Alias
UMLS CUI [1]
C1875339
patient received no myelosuppressive chemo within 14 days
Description

chemotherapy myelosuppressive

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C1513793
< 14 days have elapsed since local palliative xrt (small port) < 28 days since prior craniospinal xrt or 50% radiation of pelvis <28 days if other substantial bm radiation
Description

radiotherapy palliative

Data type

boolean

Alias
UMLS CUI [1,1]
C0034619
UMLS CUI [1,2]
C1285530
hematopoietic growth factors within 7 days of entry (except erythropoietin.)
Description

hematopoietic growth factors

Data type

boolean

Alias
UMLS CUI [1]
C0079490
patient has taken any biologic agents within 14 days
Description

drug biologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205460
post bmt/sct - evidence of active gvhd, at least > 3 months must have elapsed
Description

Graft-versus-host disease

Data type

boolean

Alias
UMLS CUI [1]
C0018133
patient has uncontrolled infection (if patients with fungal disease, stable for < 14 days and patients with bacteremia without negative blood culture
Description

bacteremia; infection uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0004610
UMLS CUI [2,1]
C3714514
UMLS CUI [2,2]
C0205318
existing non-hematologic toxicities > grade 2
Description

toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0600688
use of steroids or hydroxyurea is permitted upto 14 days prior to entry.
Description

steroids; hydroxyurea

Data type

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0020402
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Similar models

Eligibility Cancer NCT01162551

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01162551
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age; Acute lymphocytic leukemia; recurrence
Item
patients </= 25 years of age, at time of enrollment, with second or greater relapse of all or nhl. for all must have histologic diagnosis with >10% blasts in the marrow and for lymphoblastic lymphoma or peripheral t-cell lymphoma must have radiologic or physical evidence of recurrence.
boolean
C0001779 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
C0034897 (UMLS CUI [3])
Lansky Play-Performance Status; Karnofsky Performance Status
Item
lansky > 50% or karnofsky > 50%
boolean
C1522275 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
creatinine clearance; age; gender
Item
creatinine clearance or radioisotope gfr > 70ml/min/m2 or serum creatinine based on age /gender
boolean
C0373595 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
pulse oximetry
Item
pulse ox >94%
boolean
C0034108 (UMLS CUI [1])
total bilirubin
Item
total bilirubin <1.5 x normal for age
boolean
C0201913 (UMLS CUI [1])
Alanine Transaminase
Item
alt < 5 x normal for age
boolean
C1557189 (UMLS CUI [1])
albumin
Item
albumin > 2g/dl
boolean
C0201838 (UMLS CUI [1])
ejection fraction
Item
shortening fraction by echo > 28% or ejection fraction > 50% by gated radionuclide study
boolean
C0489482 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
hypersensitivity sirolimus
Item
patient has known allergies to sirolimus,fk-506 or mtor inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C0072980 (UMLS CUI [1,2])
investigational anti-neoplastic drugs other
Item
patient is taking other investigational anti-neoplastic drugs
boolean
C1875339 (UMLS CUI [1])
chemotherapy myelosuppressive
Item
patient received no myelosuppressive chemo within 14 days
boolean
C3665472 (UMLS CUI [1,1])
C1513793 (UMLS CUI [1,2])
radiotherapy palliative
Item
< 14 days have elapsed since local palliative xrt (small port) < 28 days since prior craniospinal xrt or 50% radiation of pelvis <28 days if other substantial bm radiation
boolean
C0034619 (UMLS CUI [1,1])
C1285530 (UMLS CUI [1,2])
hematopoietic growth factors
Item
hematopoietic growth factors within 7 days of entry (except erythropoietin.)
boolean
C0079490 (UMLS CUI [1])
drug biologic
Item
patient has taken any biologic agents within 14 days
boolean
C0013227 (UMLS CUI [1,1])
C0205460 (UMLS CUI [1,2])
Graft-versus-host disease
Item
post bmt/sct - evidence of active gvhd, at least > 3 months must have elapsed
boolean
C0018133 (UMLS CUI [1])
bacteremia; infection uncontrolled
Item
patient has uncontrolled infection (if patients with fungal disease, stable for < 14 days and patients with bacteremia without negative blood culture
boolean
C0004610 (UMLS CUI [1])
C3714514 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
toxicity
Item
existing non-hematologic toxicities > grade 2
boolean
C0600688 (UMLS CUI [1])
steroids; hydroxyurea
Item
use of steroids or hydroxyurea is permitted upto 14 days prior to entry.
boolean
C0038317 (UMLS CUI [1])
C0020402 (UMLS CUI [2])
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