ID

42766

Beskrivning

Targeted Radiotherapy in HSCT for Poor Risk Haematological Malignancy; ODM derived from: https://clinicaltrials.gov/show/NCT01521611

Länk

https://clinicaltrials.gov/show/NCT01521611

Nyckelord

Versioner (2)
  1. 2015-12-07 2015-12-07 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Acute Leukaemia NCT01521611

Engelsk

Eligibility Acute Leukaemia NCT01521611

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
an underlying haematological malignancy including acute myeloid leukaemia in cr1 but with poor prognostic features or in >cr1 or in relapse; acute lymphoblastic leukaemia; transformed myelodysplasia, chronic myeloid leukaemia (accelerated phase or blast transformation, poor response or intolerance of tyrosine kinase inhibitors), myeloma. patients may be in remission, partial remission or relapse.
Beskrivning

haematological malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0376545
no concurrent or recent (within 3 weeks) chemotherapy for the underlying haematological condition
Beskrivning

chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
for patients with relapsed leukaemia, bm blasts must represent < 20 percent of bm nucleated cells.
Beskrivning

patients with relapsed leukaemia, bm blasts must represent < 20 percent of bm nucleated cells.

Datatyp

boolean

Alias
UMLS CUI [1]
C1982687
UMLS CUI [2]
C0920028
although the bm remission status is not important, patients must have cellularity > 10 percent.
Beskrivning

although the bm remission status is not important, patients must have cellularity > 10 percent

Datatyp

boolean

Alias
UMLS CUI [1]
C1561532
as malignant plasma cells may or may not express cd66 antigens, patients with myeloma must have less than 30 percent plasma cells (as a percentage of total nucleated cells) in the bm at the time of the study.
Beskrivning

as malignant plasma cells may or may not express cd66 antigens, patients with myeloma must have less than 30 percent plasma cells (as a percentage of total nucleated cells) in the bm at the time of the study

Datatyp

boolean

Alias
UMLS CUI [1]
C0848076
UMLS CUI [2]
C0108797
UMLS CUI [3]
C1319846
age = or >18 yrs.
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
who performance status of 0, 1 or 2 (appendix 5).
Beskrivning

who performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
predicted life-expectancy of greater than four months.
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
patients must be negative for human anti-mouse antibodies (hama).
Beskrivning

human anti-mouse antibodies

Datatyp

boolean

Alias
UMLS CUI [1]
C1291910
wbc < 30 x 109/l (absolute neutrophil count >0.5 x 109/l) platelets > 50 x 109/l (platelet support is permitted)
Beskrivning

peripheral blood counts

Datatyp

boolean

Alias
UMLS CUI [1]
C0005771
plasma creatinine < 120 micromol/l (or creatinine clearance or edta clearance > 50 ml/min) plasma bilirubin < 30 micromol/l ast no more than 2.5 x upper limit of the normal range.
Beskrivning

biochemical indices

Datatyp

boolean

Alias
UMLS CUI [1]
C1278055
UMLS CUI [2]
C1278036
patient must be able to provide written informed consent.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious intercurrent disease.
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
patients with bm cellularity < 10%.
Beskrivning

patients with bm cellularity < 10%

Datatyp

boolean

Alias
UMLS CUI [1]
C1561532
history of atopic asthma, eczema or allergy to rodent protein, confirmed history of severe allergic reactions to penicillin or streptomycin.
Beskrivning

history of atopic asthma, eczema or allergy to rodent protein, confirmed history of severe allergic reactions to penicillin or streptomycin

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0038425
UMLS CUI [3]
C0030842
positive hama.
Beskrivning

positive hama

Datatyp

boolean

Alias
UMLS CUI [1]
C1291910
patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health.
Beskrivning

patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
pregnancy
Beskrivning

pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
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Similar models

Eligibility Acute Leukaemia NCT01521611

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
haematological malignancy
Item
an underlying haematological malignancy including acute myeloid leukaemia in cr1 but with poor prognostic features or in >cr1 or in relapse; acute lymphoblastic leukaemia; transformed myelodysplasia, chronic myeloid leukaemia (accelerated phase or blast transformation, poor response or intolerance of tyrosine kinase inhibitors), myeloma. patients may be in remission, partial remission or relapse.
boolean
C0376545 (UMLS CUI [1])
chemotherapy
Item
no concurrent or recent (within 3 weeks) chemotherapy for the underlying haematological condition
boolean
C0392920 (UMLS CUI [1])
patients with relapsed leukaemia, bm blasts must represent < 20 percent of bm nucleated cells.
Item
for patients with relapsed leukaemia, bm blasts must represent < 20 percent of bm nucleated cells.
boolean
C1982687 (UMLS CUI [1])
C0920028 (UMLS CUI [2])
although the bm remission status is not important, patients must have cellularity > 10 percent
Item
although the bm remission status is not important, patients must have cellularity > 10 percent.
boolean
C1561532 (UMLS CUI [1])
as malignant plasma cells may or may not express cd66 antigens, patients with myeloma must have less than 30 percent plasma cells (as a percentage of total nucleated cells) in the bm at the time of the study
Item
as malignant plasma cells may or may not express cd66 antigens, patients with myeloma must have less than 30 percent plasma cells (as a percentage of total nucleated cells) in the bm at the time of the study.
boolean
C0848076 (UMLS CUI [1])
C0108797 (UMLS CUI [2])
C1319846 (UMLS CUI [3])
age
Item
age = or >18 yrs.
boolean
C0001779 (UMLS CUI [1])
who performance status
Item
who performance status of 0, 1 or 2 (appendix 5).
boolean
C1298650 (UMLS CUI [1])
life expectancy
Item
predicted life-expectancy of greater than four months.
boolean
C0023671 (UMLS CUI [1])
human anti-mouse antibodies
Item
patients must be negative for human anti-mouse antibodies (hama).
boolean
C1291910 (UMLS CUI [1])
peripheral blood counts
Item
wbc < 30 x 109/l (absolute neutrophil count >0.5 x 109/l) platelets > 50 x 109/l (platelet support is permitted)
boolean
C0005771 (UMLS CUI [1])
biochemical indices
Item
plasma creatinine < 120 micromol/l (or creatinine clearance or edta clearance > 50 ml/min) plasma bilirubin < 30 micromol/l ast no more than 2.5 x upper limit of the normal range.
boolean
C1278055 (UMLS CUI [1])
C1278036 (UMLS CUI [2])
informed consent
Item
patient must be able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
any serious intercurrent disease.
boolean
C0009488 (UMLS CUI [1])
patients with bm cellularity < 10%
Item
patients with bm cellularity < 10%.
boolean
C1561532 (UMLS CUI [1])
history of atopic asthma, eczema or allergy to rodent protein, confirmed history of severe allergic reactions to penicillin or streptomycin
Item
history of atopic asthma, eczema or allergy to rodent protein, confirmed history of severe allergic reactions to penicillin or streptomycin.
boolean
C0020517 (UMLS CUI [1])
C0038425 (UMLS CUI [2])
C0030842 (UMLS CUI [3])
positive hama
Item
positive hama.
boolean
C1291910 (UMLS CUI [1])
patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health
Item
patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health.
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
pregnancy
Item
pregnancy
boolean
C0549206 (UMLS CUI [1])
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