ID

12658

Description

Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00144963

Link

https://clinicaltrials.gov/show/NCT00144963

Keywords

Versions (1)
  1. 12/8/15 12/8/15 -
Uploaded on

December 8, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00144963

English

Eligibility Acute Lymphoblastic Leukemia NCT00144963

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously treated, relapsed or refractory all (including lymphoblastic lymphoma and burkitt's subtypes) with measurable disease.
Description

previously treated, relapsed or refractory all

Data type

boolean

Alias
UMLS CUI [1]
C0278785
performance status ≤3 (ecog).
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
all ages are eligible. those aged 12 years or older may be counted towards the mtd in the phase i portion of the trial. pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
Description

all ages are eligible

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
Description

liver and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232805
negative pregnancy test in females of childbearing potential.
Description

pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.
Description

history of stem cell transplant are eligible

Data type

boolean

Alias
UMLS CUI [1]
C1504389
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active serious infection not controlled by oral or intravenous antibiotics.
Description

active serious infection not controlled

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0003232
treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the investigator.
Description

Study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
concurrent treatment with other anti-cancer agents other than dexamethasone.
Description

concurrent medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0013227
known cns leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with cns neuropathy limiting evaluation of study drug. patients with controlled cns disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the principal investigator. lumbar puncture not required in asymptomatic patients.
Description

known cns leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with cns neuropathy limiting evaluation of study drug

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
prior history of grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent grade 2 or greater active neuropathy.
Description

active neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
history of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
Description

neurologic disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
prior history of hypersensitivity reactions to vincristine or any of the other components of vsli.
Description

hypersensitivity reactions to vincristine or any of the other components of vsli

Data type

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0042679
pregnant and/or lactating women; or fertile men or women not willing to use contraception.
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00144963

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
previously treated, relapsed or refractory all
Item
previously treated, relapsed or refractory all (including lymphoblastic lymphoma and burkitt's subtypes) with measurable disease.
boolean
C0278785 (UMLS CUI [1])
ecog performance status
Item
performance status ≤3 (ecog).
boolean
C1520224 (UMLS CUI [1])
all ages are eligible
Item
all ages are eligible. those aged 12 years or older may be counted towards the mtd in the phase i portion of the trial. pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
boolean
C0001779 (UMLS CUI [1])
liver and renal function
Item
adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
boolean
C0232741 (UMLS CUI [1])
C0232805 (UMLS CUI [2])
pregnancy test negative
Item
negative pregnancy test in females of childbearing potential.
boolean
C0427780 (UMLS CUI [1])
history of stem cell transplant are eligible
Item
patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.
boolean
C1504389 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
active serious infection not controlled
Item
active serious infection not controlled by oral or intravenous antibiotics.
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2])
Study subject participation status
Item
treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the investigator.
boolean
C2348568 (UMLS CUI [1])
concurrent medication
Item
concurrent treatment with other anti-cancer agents other than dexamethasone.
boolean
C0205420 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
known cns leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with cns neuropathy limiting evaluation of study drug
Item
known cns leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with cns neuropathy limiting evaluation of study drug. patients with controlled cns disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the principal investigator. lumbar puncture not required in asymptomatic patients.
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
active neuropathy
Item
prior history of grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent grade 2 or greater active neuropathy.
boolean
C0442874 (UMLS CUI [1])
neurologic disorders
Item
history of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
boolean
C0027765 (UMLS CUI [1])
hypersensitivity reactions to vincristine or any of the other components of vsli
Item
prior history of hypersensitivity reactions to vincristine or any of the other components of vsli.
boolean
C0020517 (UMLS CUI [1])
C0042679 (UMLS CUI [2])
pregnant or breastfeeding
Item
pregnant and/or lactating women; or fertile men or women not willing to use contraception.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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