ID

42064

Descrição

Treating High Risk Leukemia With CD40 Ligand & IL-2 Gene Modified Tumor Vaccine; ODM derived from: https://clinicaltrials.gov/show/NCT00058799

Link

https://clinicaltrials.gov/show/NCT00058799

Palavras-chave

Versões (2)
  1. 11/04/2016 11/04/2016 -
  2. 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Transferido a

15 de março de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Leukemia NCT00058799

Inglês

Eligibility Leukemia NCT00058799

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00058799
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Descrição

Patient and disease status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0023449
UMLS CUI [3]
C0023467
UMLS CUI [4]
C1982687
UMLS CUI [5]
C3463824
UMLS CUI [6]
C0544452
UMLS CUI [7]
C0392920
UMLS CUI [8]
C0005961
UMLS CUI [9]
C0277556
UMLS CUI [10]
C1328050
2. patients must have a life expectancy of at least 10 weeks.
Descrição

Life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
3. patients must have ecog performance status of 0-2 as below:
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
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.
Descrição

Toxic effects of chemotherapy and laboratory parameters

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C2004454
UMLS CUI [2]
C0948762
UMLS CUI [3]
C3544087
UMLS CUI [4]
C0032181
5. patients must not have active gvhd at the time of protocol entry.
Descrição

GvHD

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018133
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)
Descrição

Immunosuppressive therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2]
C0021081
UMLS CUI [3]
C3173309
7. patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic septra.)
Descrição

Infections and antibiotics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0003232
8. patients must not be hiv-positive.
Descrição

HIV Seronegativity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019698
9. patients must have adequate liver function (bilirubin<1.5 mg% sgot<2x normal, normal prothrombin time).
Descrição

Bilirubin, sgot and prothrombin time

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0033707
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.
Descrição

Specification: transduced cells

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0167627
UMLS CUI [2]
C0021756
UMLS CUI [3]
C0085295
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.
Descrição

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
12. patient must not have received treatment with other investigational agents within the last 4 weeks.
Descrição

Experimental drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304229
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.
Descrição

Contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. rapidly progressive/refractory disease (>20% blasts infiltrating the bone marrow)
Descrição

Blasts infiltrating bone marrow

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1982687
2. life expectancy < 10 weeks
Descrição

Life expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
3. active infection
Descrição

Active infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
4. need for concomitant drugs except analgesics
Descrição

Concomitant drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0002771
5. pregnancy or lactation
Descrição

Gynaecological status

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
6. seropositive for hiv
Descrição

HIV seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Leukemia NCT00058799

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00058799
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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