ID

12801

Beskrivning

Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00983528

Länk

https://clinicaltrials.gov/show/NCT00983528

Nyckelord

Versioner (1)
  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

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Creative Commons BY 4.0
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Eligibility Acute Lymphoblastic Leukemia NCT00983528

Engelsk

Eligibility Acute Lymphoblastic Leukemia NCT00983528

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
provide signed written informed consent. if a patient is under 18 years of age the parent or the guardian will also need to provide written informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
diagnosis of all (b or t lineage) who have received therapy with at least 1 but not more than 3 prior different induction regimens and have been deemed to have relapse or refractory disease. the phase ii component of the study enrollment will be limited to 2 different prior induction regimens if patients are older than 30 years.
Beskrivning

all, refractory disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0277556
all lymphoblasts with cd52 expression on at least 10 percent on lymphoblasts.
Beskrivning

cd52 expression

Datatyp

boolean

Alias
UMLS CUI [1]
C1267944
age >= 16 years of age.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog ps 0-2.
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
have adequate renal and hepatic functions.
Beskrivning

renal and hepatic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232805
UMLS CUI [2]
C1848676
subject or their patient or guardian is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Beskrivning

subject or their patient or guardian is capable of understanding the investigational nature

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0162340
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Beskrivning

negative pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1]
C0427780
male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. subjects 16 and 17 years old must also adhere to effective contraception methods or abstinence during the study and for a minimum of 6 months after study and the nature of contraception or abstinence must be documented.
Beskrivning

contraceptive method

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
cmv pcr negative prior to enrollment
Beskrivning

cmv pcr negative

Datatyp

boolean

Alias
UMLS CUI [1]
C2120945
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Beskrivning

current concomitant chemotherapy, radiation therapy, or immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, cns treatment or prophylaxis, or tyrosine kinase inhibitors for individuals with philadelphia chromosome positive all. the patient must have recovered from all acute toxicities from any previous therapy.
Beskrivning

study subject participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
lack of bone marrow or blood involvement by leukemia such as a documented cns or testicular only relapse.
Beskrivning

cns or testicular only relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C3714787
UMLS CUI [3]
C0039590
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 that may place the patient at undue risk to undergo treatment.
Beskrivning

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
patients with any known or suspected hepatitis b, c and hiv infections.
Beskrivning

infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Beskrivning

infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or lactating patients.
Beskrivning

pregnant or breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Beskrivning

significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
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Similar models

Eligibility Acute Lymphoblastic Leukemia NCT00983528

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
provide signed written informed consent. if a patient is under 18 years of age the parent or the guardian will also need to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
all, refractory disease
Item
diagnosis of all (b or t lineage) who have received therapy with at least 1 but not more than 3 prior different induction regimens and have been deemed to have relapse or refractory disease. the phase ii component of the study enrollment will be limited to 2 different prior induction regimens if patients are older than 30 years.
boolean
C0023449 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
cd52 expression
Item
all lymphoblasts with cd52 expression on at least 10 percent on lymphoblasts.
boolean
C1267944 (UMLS CUI [1])
age
Item
age >= 16 years of age.
boolean
C0001779 (UMLS CUI [1])
ecog
Item
ecog ps 0-2.
boolean
C1520224 (UMLS CUI [1])
renal and hepatic function
Item
have adequate renal and hepatic functions.
boolean
C0232805 (UMLS CUI [1])
C1848676 (UMLS CUI [2])
subject or their patient or guardian is capable of understanding the investigational nature
Item
subject or their patient or guardian is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2])
negative pregnancy test
Item
female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
boolean
C0427780 (UMLS CUI [1])
contraceptive method
Item
male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. subjects 16 and 17 years old must also adhere to effective contraception methods or abstinence during the study and for a minimum of 6 months after study and the nature of contraception or abstinence must be documented.
boolean
C0700589 (UMLS CUI [1])
cmv pcr negative
Item
cmv pcr negative prior to enrollment
boolean
C2120945 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
current concomitant chemotherapy, radiation therapy, or immunotherapy
Item
current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
study subject participation status
Item
use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, cns treatment or prophylaxis, or tyrosine kinase inhibitors for individuals with philadelphia chromosome positive all. the patient must have recovered from all acute toxicities from any previous therapy.
boolean
C2348568 (UMLS CUI [1])
cns or testicular only relapse
Item
lack of bone marrow or blood involvement by leukemia such as a documented cns or testicular only relapse.
boolean
C0277556 (UMLS CUI [1])
C3714787 (UMLS CUI [2])
C0039590 (UMLS CUI [3])
Comorbidity
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 that may place the patient at undue risk to undergo treatment.
boolean
C0009488 (UMLS CUI [1])
infection
Item
patients with any known or suspected hepatitis b, c and hiv infections.
boolean
C0009450 (UMLS CUI [1])
infection
Item
patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
boolean
C0009450 (UMLS CUI [1])
pregnant or breastfeeding
Item
pregnant or lactating patients.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation
Item
any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
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