ID

13251

Beskrivning

Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission; ODM derived from: https://clinicaltrials.gov/show/NCT00834002

Länk

https://clinicaltrials.gov/show/NCT00834002

Nyckelord

Versioner (1)
  1. 2016-01-26 2016-01-26 -
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CC BY-NC 3.0

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26 januari 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia (AML) NCT00834002

Engelsk

Eligibility Acute Myeloid Leukemia (AML) NCT00834002

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. tumor type: acute myeloid leukemia (aml) according to the who criteria (ea at least 20% blasts in the marrow). all fab subtypes except m3. patients with myelodysplastic syndrome, category of refractory anemia with excess blasts (raeb): raeb i (who: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and raeb ii (who: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
Beskrivning

AML, MDS

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
2. extent of disease: remission (partial or complete) or smouldering course. complete remission (cr) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. this definition is related to the hematological remission if it is not specified. partial remission (pr) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.
Beskrivning

remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0544452
3. overexpression of wt1 rna (>50 copies of wt1 per 1000 copies abl in bone marrow or >2 copy/1000 copies abl in peripheral blood) as assessed by quantitative rt-pcr at the time of presentation.
Beskrivning

wt1 expression

Datatyp

boolean

Alias
UMLS CUI [1]
C0694898
4. prior treatments : patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.
Beskrivning

prior treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1504389
5. age: ≥ 18 years
Beskrivning

age: ≥ 18 years

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
6. high risk of relapse because of (and/or) age > 60 years (if <60 y, no sibling allotransplant donor available) poor risk cytogenetic or molecular markers at presentation second complete remission after relapse hyperleukocytosis at presentation
Beskrivning

high risk of relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
7. performance status: who ps grade 0-1 (appendix b)
Beskrivning

WHO performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
8. objectively assessable parameters of life expectancy: more than 3 months
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
9. prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv
Beskrivning

prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
10. no concomitant use of immunosuppressive drugs
Beskrivning

immunosuppressive agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
11. adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
Beskrivning

renal and liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
12. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Beskrivning

absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
13. women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
Beskrivning

contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
Beskrivning

malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
2. subjects who are pregnant
Beskrivning

pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
3. subjects who have sensitivity to drugs that provide local anesthesia
Beskrivning

sensitivity to drugs that provide local anesthesia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002921
4. age < 18 years
Beskrivning

age < 18 years

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Acute Myeloid Leukemia (AML) NCT00834002

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML, MDS
Item
1. tumor type: acute myeloid leukemia (aml) according to the who criteria (ea at least 20% blasts in the marrow). all fab subtypes except m3. patients with myelodysplastic syndrome, category of refractory anemia with excess blasts (raeb): raeb i (who: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and raeb ii (who: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
remission
Item
2. extent of disease: remission (partial or complete) or smouldering course. complete remission (cr) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. this definition is related to the hematological remission if it is not specified. partial remission (pr) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.
boolean
C0544452 (UMLS CUI [1])
wt1 expression
Item
3. overexpression of wt1 rna (>50 copies of wt1 per 1000 copies abl in bone marrow or >2 copy/1000 copies abl in peripheral blood) as assessed by quantitative rt-pcr at the time of presentation.
boolean
C0694898 (UMLS CUI [1])
prior treatment
Item
4. prior treatments : patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.
boolean
C0392920 (UMLS CUI [1])
C1504389 (UMLS CUI [2])
age: ≥ 18 years
Item
5. age: ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
high risk of relapse
Item
6. high risk of relapse because of (and/or) age > 60 years (if <60 y, no sibling allotransplant donor available) poor risk cytogenetic or molecular markers at presentation second complete remission after relapse hyperleukocytosis at presentation
boolean
C0277556 (UMLS CUI [1])
WHO performance status
Item
7. performance status: who ps grade 0-1 (appendix b)
boolean
C1298650 (UMLS CUI [1])
life expectancy
Item
8. objectively assessable parameters of life expectancy: more than 3 months
boolean
C0023671 (UMLS CUI [1])
prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv
Item
9. prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv
boolean
C0009488 (UMLS CUI [1])
immunosuppressive agents
Item
10. no concomitant use of immunosuppressive drugs
boolean
C0021081 (UMLS CUI [1])
renal and liver function
Item
11. adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Item
12. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
contraception
Item
13. women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancy
Item
1. subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
boolean
C0006826 (UMLS CUI [1])
pregnancy
Item
2. subjects who are pregnant
boolean
C0032961 (UMLS CUI [1])
sensitivity to drugs that provide local anesthesia
Item
3. subjects who have sensitivity to drugs that provide local anesthesia
boolean
C0020517 (UMLS CUI [1,1])
C0002921 (UMLS CUI [1,2])
age < 18 years
Item
4. age < 18 years
boolean
C0001779 (UMLS CUI [1])
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