Patient and disease status
Item
1. patients less than or equal to 75 years old with lymphoid (pre-b, b, t, non b-, non t, or burkitt if bone marrow blasts > 20%) or acute myeloid leukemia (m0 to m7) or myelodysplastic syndrome and with: disease that has entered remission with chemotherapy and/or bone marrow transplantation, but is considered to be at high risk of relapse. or primary, or relapsed treatment-refractory disease who, at the time of reinjection of the tumor vaccine, are at a state of complete or partial cytological remission disease (<20% blasts infiltrating the bone marrow) after a second/higher line of conventional and/or high dose chemotherapy.
boolean
C0001779 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C1982687 (UMLS CUI [4])
C3463824 (UMLS CUI [5])
C0544452 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
C0005961 (UMLS CUI [8])
C0277556 (UMLS CUI [9])
C1328050 (UMLS CUI [10])
Life expectancy
Item
2. patients must have a life expectancy of at least 10 weeks.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
3. patients must have ecog performance status of 0-2 as below:
boolean
C1520224 (UMLS CUI [1])
Toxic effects of chemotherapy and laboratory parameters
Item
4. patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute neutrophil count >500/mm3, absolute lymphocyte count >200/mm3, and platelet count >50,000/mm3.
boolean
C0600688 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2004454 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C3544087 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
GvHD
Item
5. patients must not have active gvhd at the time of protocol entry.
boolean
C0018133 (UMLS CUI [1])
Immunosuppressive therapy
Item
6. patient has not received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
boolean
C0038317 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C3173309 (UMLS CUI [3])
Infections and antibiotics
Item
7. patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic septra.)
boolean
C0009450 (UMLS CUI [1])
C0003232 (UMLS CUI [2])
HIV Seronegativity
Item
8. patients must not be hiv-positive.
boolean
C0019698 (UMLS CUI [1])
Bilirubin, sgot and prothrombin time
Item
9. patients must have adequate liver function (bilirubin<1.5 mg% sgot<2x normal, normal prothrombin time).
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
Specification: transduced cells
Item
10. patients must have transduced cells available that are demonstrably >20% cd40l expressing fibroblasts and producing>150 pg il-2/10 6 cell/24 hr.
boolean
C0167627 (UMLS CUI [1])
C0021756 (UMLS CUI [2])
C0085295 (UMLS CUI [3])
Informed consent
Item
11. patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. patients or their guardians will be given a copy of the consent form.
boolean
C0021430 (UMLS CUI [1])
Experimental drugs
Item
12. patient must not have received treatment with other investigational agents within the last 4 weeks.
boolean
C0304229 (UMLS CUI [1])
Contraception
Item
13. patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. the male partner should use a condom.
boolean
C0700589 (UMLS CUI [1])
Blasts infiltrating bone marrow
Item
1. rapidly progressive/refractory disease (>20% blasts infiltrating the bone marrow)
boolean
C1982687 (UMLS CUI [1])
Life expectancy
Item
2. life expectancy < 10 weeks
boolean
C0023671 (UMLS CUI [1])
Active infection
Item
3. active infection
boolean
C0009450 (UMLS CUI [1])
Concomitant drugs
Item
4. need for concomitant drugs except analgesics
boolean
C2347852 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C0002771 (UMLS CUI [2,2])
Gynaecological status
Item
5. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
HIV seropositivity
Item
6. seropositive for hiv
boolean
C0019699 (UMLS CUI [1])