ID

13162

Description

A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I); ODM derived from: https://clinicaltrials.gov/show/NCT00317642

Link

https://clinicaltrials.gov/show/NCT00317642

Keywords

Versions (1)
  1. 1/20/16 1/20/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 20, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT00317642

English

Eligibility Acute Myelogenous Leukemia NCT00317642

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of acute myelogenous leukemia (aml) according to world health organization (who) classification
Description

AML

Data type

boolean

Alias
UMLS CUI [1]
C0023467
relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy induction regimen
Description

relapsed or refractory

Data type

boolean

Alias
UMLS CUI [1]
C0392920
be ≥ 55 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have an eastern cooperative oncology group (ecog) score of 0-2
Description

ecog score

Data type

boolean

Alias
UMLS CUI [1]
C1520224
be able to comply with study procedures and follow-up examinations
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
be nonfertile or agree to use birth control during the study through the end of treatment visit and for at least 90 days after the last dose of study drug
Description

fertility and contraception

Data type

boolean

Alias
UMLS CUI [1]
C0015895
UMLS CUI [2]
C0700589
have adequate liver and renal function as indicated by certain laboratory values
Description

liver and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous treatment with clofarabine
Description

clofarabine

Data type

boolean

Alias
UMLS CUI [1]
C0092777
received bolus, intermediate or high-dose cytarabine as induction therapy unless certain remission criteria are met
Description

cytarabine

Data type

boolean

Alias
UMLS CUI [1]
C0010711
have received a hematopoietic stem cell transplant (hsct) within the previous 3 months
Description

hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C0472699
have moderate or severe graft versus host disease (gvhd), whether acute or chronic
Description

graft versus host disease

Data type

boolean

Alias
UMLS CUI [1]
C0018133
are receiving any other chemotherapy or investigational therapy. patients must have been off prior aml therapy for at least 2-6 weeks prior to entering study.
Description

chemotherapy or investigational therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0013230
have a psychiatric disorder that would interfere with consent, study participation, or follow-up
Description

psychiatric disorder that would interfere with consent, study participation, or follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
have an active, uncontrolled infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system
Description

severe concurrent disease, or have a history of serious organ dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0009488
have been diagnosed with another malignancy, unless disease-free for at least 5 years; patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
have clinical evidence suggestive of central nervous system (cns) involvement with leukemia unless lumbar puncture confirms absence of leukemic blasts in the cerebrospinal fluid(csf)
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
known hiv positivity
Description

HIV

Data type

boolean

Alias
UMLS CUI [1]
C0019682
are pregnant or lactating
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00317642

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
have a diagnosis of acute myelogenous leukemia (aml) according to world health organization (who) classification
boolean
C0023467 (UMLS CUI [1])
relapsed or refractory
Item
relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy induction regimen
boolean
C0392920 (UMLS CUI [1])
age
Item
be ≥ 55 years of age
boolean
C0001779 (UMLS CUI [1])
ecog score
Item
have an eastern cooperative oncology group (ecog) score of 0-2
boolean
C1520224 (UMLS CUI [1])
compliance
Item
be able to comply with study procedures and follow-up examinations
boolean
C1321605 (UMLS CUI [1])
fertility and contraception
Item
be nonfertile or agree to use birth control during the study through the end of treatment visit and for at least 90 days after the last dose of study drug
boolean
C0015895 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
liver and renal function
Item
have adequate liver and renal function as indicated by certain laboratory values
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
clofarabine
Item
received previous treatment with clofarabine
boolean
C0092777 (UMLS CUI [1])
cytarabine
Item
received bolus, intermediate or high-dose cytarabine as induction therapy unless certain remission criteria are met
boolean
C0010711 (UMLS CUI [1])
hematopoietic stem cell transplant
Item
have received a hematopoietic stem cell transplant (hsct) within the previous 3 months
boolean
C0472699 (UMLS CUI [1])
graft versus host disease
Item
have moderate or severe graft versus host disease (gvhd), whether acute or chronic
boolean
C0018133 (UMLS CUI [1])
chemotherapy or investigational therapy
Item
are receiving any other chemotherapy or investigational therapy. patients must have been off prior aml therapy for at least 2-6 weeks prior to entering study.
boolean
C0392920 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
psychiatric disorder that would interfere with consent, study participation, or follow-up
Item
have a psychiatric disorder that would interfere with consent, study participation, or follow-up
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
infection
Item
have an active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
severe concurrent disease, or have a history of serious organ dysfunction
Item
have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system
boolean
C0009488 (UMLS CUI [1])
malignancy
Item
have been diagnosed with another malignancy, unless disease-free for at least 5 years; patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed.
boolean
C0006826 (UMLS CUI [1])
cns leukemia
Item
have clinical evidence suggestive of central nervous system (cns) involvement with leukemia unless lumbar puncture confirms absence of leukemic blasts in the cerebrospinal fluid(csf)
boolean
C1332884 (UMLS CUI [1])
HIV
Item
known hiv positivity
boolean
C0019682 (UMLS CUI [1])
pregnancy or lactation
Item
are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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