ID

42766

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01521611

Stichworte

Versionen (2)
  1. 07.12.15 07.12.15 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

17. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Acute Leukaemia NCT01521611

Englisch

Eligibility Acute Leukaemia NCT01521611

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

haematological malignancy

Datentyp

boolean

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

chemotherapy

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

age

Datentyp

boolean

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

who performance status

Datentyp

boolean

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

life expectancy

Datentyp

boolean

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

human anti-mouse antibodies

Datentyp

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)
Beschreibung

peripheral blood counts

Datentyp

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.
Beschreibung

biochemical indices

Datentyp

boolean

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

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any serious intercurrent disease.
Beschreibung

comorbidity

Datentyp

boolean

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

patients with bm cellularity < 10%

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

positive hama

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0549206
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Ähnliche Modelle

Eligibility Acute Leukaemia NCT01521611

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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