ID

13137

Description

Study of Liposomal Annamycin in Patients With Refractory or Relapsed Acute Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00271063

Link

https://clinicaltrials.gov/show/NCT00271063

Keywords

Versions (1)
  1. 1/19/16 1/19/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 19, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Lymphocytic Leukemia NCT00271063

English

Eligibility Acute Lymphocytic Leukemia NCT00271063

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of refractory or relapsed all (acute lymphocytic leukemia)
Description

ALL

Data type

boolean

Alias
UMLS CUI [1]
C0023449
age greater than or equal to 15 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
no chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
Description

chemotherapy, radiation, or major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0543467
no investigational therapy within 4 weeks of first dose of study drug
Description

investigational drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
ecog performance status (ps) 0 to 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate liver function
Description

liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
adequate renal function
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
signed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concommitant therapy that includes other chemotherapy that is or may be active against all (except central nervous system [cns] therapy)
Description

concommitant therapy that includes other chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Description

condition limiting study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
cardiac ejection fraction less than 40%
Description

cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
clinically relevant serious co-morbid medical conditions.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
pregnant, lactating or not using adequate contraception.
Description

pregnant, lactating or not using adequate contraception

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
known allergy to doxorubicin or anthracyclines.
Description

allergy to doxorubicin or anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013089
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0282564
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Similar models

Eligibility Acute Lymphocytic Leukemia NCT00271063

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ALL
Item
diagnosis of refractory or relapsed all (acute lymphocytic leukemia)
boolean
C0023449 (UMLS CUI [1])
age
Item
age greater than or equal to 15 years
boolean
C0001779 (UMLS CUI [1])
chemotherapy, radiation, or major surgery
Item
no chemotherapy, radiation, or major surgery within 2 weeks prior to first dose of study drug and recovered from toxic side effects of that therapy, unless treatment is indicated due to progressive disease.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
investigational drugs
Item
no investigational therapy within 4 weeks of first dose of study drug
boolean
C0013230 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status (ps) 0 to 2.
boolean
C1520224 (UMLS CUI [1])
liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
concommitant therapy that includes other chemotherapy
Item
concommitant therapy that includes other chemotherapy that is or may be active against all (except central nervous system [cns] therapy)
boolean
C0392920 (UMLS CUI [1])
condition limiting study protocol
Item
any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
cardiac ejection fraction
Item
cardiac ejection fraction less than 40%
boolean
C0232174 (UMLS CUI [1])
comorbidity
Item
clinically relevant serious co-morbid medical conditions.
boolean
C0009488 (UMLS CUI [1])
pregnant, lactating or not using adequate contraception
Item
pregnant, lactating or not using adequate contraception.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
allergy to doxorubicin or anthracyclines
Item
known allergy to doxorubicin or anthracyclines.
boolean
C0020517 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0282564 (UMLS CUI [2,2])
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