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])
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])