ID

21489

Beskrivning

Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00388531

Länk

https://clinicaltrials.gov/show/NCT00388531

Nyckelord

Versioner (1)
  1. 2017-04-24 2017-04-24 -
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24 april 2017

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoblastic Leukemia NCT00388531

Engelsk

Eligibility Lymphoblastic Leukemia NCT00388531

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with acute lymphoblastic leukemia or very aggressive non-hodgkin-lymphoma (burkitt/burkitt-like) and cns relapse.
Beskrivning

Acute lymphocytic leukemia | Very Aggressive Non-Hodgkin Lymphoma | Burkitt Lymphoma | Burkitt-like lymphoma | Central nervous system leukaemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2,1]
C1332225
UMLS CUI [2,2]
C0442824
UMLS CUI [3]
C0006413
UMLS CUI [4]
C1368771
UMLS CUI [5]
C1332884
cns involvement must be demonstrated by:
Beskrivning

Central Nervous System Involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C4050309
a positive ventricular or lumbar csf cytology defined as csf cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion or
Beskrivning

Ventricular CSF Positive Cytology | Cerebrospinal Fluid Lumbar Positive Cytology | Cell count, cerebrospinal fluid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1550320
UMLS CUI [1,2]
C3846509
UMLS CUI [2,1]
C0007806
UMLS CUI [2,2]
C0024090
UMLS CUI [2,3]
C3846509
UMLS CUI [3]
C0427874
characteristic signs and symptoms of neoplastic meningitis plus an mri or ct scan indicating the presence of meningeal involvement. patients with combined relapse in cns and other locations may be included in case that systemic therapy with cns active drugs (hdmtx;hdac, thiotepa) can be postponed for at least 2 weeks.
Beskrivning

Neoplastic meningitis Signs and Symptoms | Involvement meningeal Magnetic Resonance Imaging | Involvement meningeal X-Ray Computed Tomography | Central nervous system leukaemia | Location Relapse | systemic therapy | Central Nervous System Agents | Methotrexate High dose | Ara-C High dose | Thiotepa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704231
UMLS CUI [1,2]
C0037088
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0521400
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0521400
UMLS CUI [3,3]
C0040405
UMLS CUI [4]
C1332884
UMLS CUI [5,1]
C1515974
UMLS CUI [5,2]
C0277556
UMLS CUI [6]
C1515119
UMLS CUI [7]
C0007680
UMLS CUI [8,1]
C0025677
UMLS CUI [8,2]
C0444956
UMLS CUI [9,1]
C0733521
UMLS CUI [9,2]
C0444956
UMLS CUI [10]
C0039871
karnofsky >60%
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
age >18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
recovery from grade iii/iv toxicities attributable to prior treatment with the exception of hematotoxicity.
Beskrivning

Therapeutic procedure Resulting in Toxicity CTCAE Grades | Patient recovered | Haematotoxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0600688
UMLS CUI [1,4]
C1516728
UMLS CUI [2]
C1115804
UMLS CUI [3]
C0920103
no severe heart, lung, liver or kidney dysfunction.
Beskrivning

Cardiac dysfunction Severe Absent | Pulmonary Dysfunction Severe Absent | Liver Dysfunction Severe Absent | Renal dysfunction Severe Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1709770
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0086565
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3279454
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0332197
the patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures
Beskrivning

Informed Consent | Informed Consent Guardian

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
failure (as defined by no clearance of the csf) to > 1 dose of prior intrathecal mtx or cytarabine or triple (mtx, arac, dexamethasone) therapy
Beskrivning

Intrathecal therapy failed | Methotrexate Dose Quantity | Cytarabine Dose Quantity | Dexamethasone Dose Quantity | Cerebrospinal Fluid Clearance Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1831734
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0010711
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0011777
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0007806
UMLS CUI [5,2]
C1382187
UMLS CUI [5,3]
C0332197
history of previous severe neurotoxicity (grade iii-iv) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted)
Beskrivning

Intrathecal therapy | Systemic therapy High dose | Neurotoxicity Severe CTCAE Grades | Peripheral Neuropathy Vincristine Induced

Datatyp

boolean

Alias
UMLS CUI [1]
C1831734
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C0235032
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C1516728
UMLS CUI [4,1]
C0031117
UMLS CUI [4,2]
C0042679
UMLS CUI [4,3]
C0205263
prior cns relapse < 1 month before
Beskrivning

Central nervous system leukaemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
uncontrolled infection
Beskrivning

Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
the patient must not be pregnant or breast feeding. if the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430061
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
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Similar models

Eligibility Lymphoblastic Leukemia NCT00388531

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphocytic leukemia | Very Aggressive Non-Hodgkin Lymphoma | Burkitt Lymphoma | Burkitt-like lymphoma | Central nervous system leukaemia
Item
patients with acute lymphoblastic leukemia or very aggressive non-hodgkin-lymphoma (burkitt/burkitt-like) and cns relapse.
boolean
C0023449 (UMLS CUI [1])
C1332225 (UMLS CUI [2,1])
C0442824 (UMLS CUI [2,2])
C0006413 (UMLS CUI [3])
C1368771 (UMLS CUI [4])
C1332884 (UMLS CUI [5])
Central Nervous System Involvement
Item
cns involvement must be demonstrated by:
boolean
C4050309 (UMLS CUI [1])
Ventricular CSF Positive Cytology | Cerebrospinal Fluid Lumbar Positive Cytology | Cell count, cerebrospinal fluid
Item
a positive ventricular or lumbar csf cytology defined as csf cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion or
boolean
C1550320 (UMLS CUI [1,1])
C3846509 (UMLS CUI [1,2])
C0007806 (UMLS CUI [2,1])
C0024090 (UMLS CUI [2,2])
C3846509 (UMLS CUI [2,3])
C0427874 (UMLS CUI [3])
Neoplastic meningitis Signs and Symptoms | Involvement meningeal Magnetic Resonance Imaging | Involvement meningeal X-Ray Computed Tomography | Central nervous system leukaemia | Location Relapse | systemic therapy | Central Nervous System Agents | Methotrexate High dose | Ara-C High dose | Thiotepa
Item
characteristic signs and symptoms of neoplastic meningitis plus an mri or ct scan indicating the presence of meningeal involvement. patients with combined relapse in cns and other locations may be included in case that systemic therapy with cns active drugs (hdmtx;hdac, thiotepa) can be postponed for at least 2 weeks.
boolean
C1704231 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0521400 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C1314939 (UMLS CUI [3,1])
C0521400 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1332884 (UMLS CUI [4])
C1515974 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C1515119 (UMLS CUI [6])
C0007680 (UMLS CUI [7])
C0025677 (UMLS CUI [8,1])
C0444956 (UMLS CUI [8,2])
C0733521 (UMLS CUI [9,1])
C0444956 (UMLS CUI [9,2])
C0039871 (UMLS CUI [10])
Karnofsky Performance Status
Item
karnofsky >60%
boolean
C0206065 (UMLS CUI [1])
Age
Item
age >18 years old
boolean
C0001779 (UMLS CUI [1])
Therapeutic procedure Resulting in Toxicity CTCAE Grades | Patient recovered | Haematotoxicity
Item
recovery from grade iii/iv toxicities attributable to prior treatment with the exception of hematotoxicity.
boolean
C0087111 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C1115804 (UMLS CUI [2])
C0920103 (UMLS CUI [3])
Cardiac dysfunction Severe Absent | Pulmonary Dysfunction Severe Absent | Liver Dysfunction Severe Absent | Renal dysfunction Severe Absent
Item
no severe heart, lung, liver or kidney dysfunction.
boolean
C3277906 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1709770 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0086565 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3279454 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Informed Consent | Informed Consent Guardian
Item
the patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Intrathecal therapy failed | Methotrexate Dose Quantity | Cytarabine Dose Quantity | Dexamethasone Dose Quantity | Cerebrospinal Fluid Clearance Absent
Item
failure (as defined by no clearance of the csf) to > 1 dose of prior intrathecal mtx or cytarabine or triple (mtx, arac, dexamethasone) therapy
boolean
C1831734 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0010711 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0011777 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0007806 (UMLS CUI [5,1])
C1382187 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Intrathecal therapy | Systemic therapy High dose | Neurotoxicity Severe CTCAE Grades | Peripheral Neuropathy Vincristine Induced
Item
history of previous severe neurotoxicity (grade iii-iv) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted)
boolean
C1831734 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0235032 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
C0031117 (UMLS CUI [4,1])
C0042679 (UMLS CUI [4,2])
C0205263 (UMLS CUI [4,3])
Central nervous system leukaemia
Item
prior cns relapse < 1 month before
boolean
C1332884 (UMLS CUI [1])
Communicable Disease Uncontrolled
Item
uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
the patient must not be pregnant or breast feeding. if the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430061 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
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