ID

42064

Description

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

Keywords

Versions (2)
  1. 4/11/16 4/11/16 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

March 15, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00058799

English

Eligibility Leukemia NCT00058799

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00058799
Inclusion Criteria
Description

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.
Description

Patient and disease status

Data type

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.
Description

Life expectancy

Data type

boolean

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

ECOG performance status

Data type

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.
Description

Toxic effects of chemotherapy and laboratory parameters

Data type

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.
Description

GvHD

Data type

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)
Description

Immunosuppressive therapy

Data type

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.)
Description

Infections and antibiotics

Data type

boolean

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

HIV Seronegativity

Data type

boolean

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

Bilirubin, sgot and prothrombin time

Data type

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.
Description

Specification: transduced cells

Data type

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.
Description

Informed consent

Data type

boolean

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

Experimental drugs

Data type

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.
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

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

Blasts infiltrating bone marrow

Data type

boolean

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

Life expectancy

Data type

boolean

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

Active infection

Data type

boolean

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

Concomitant drugs

Data type

boolean

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

Gynaecological status

Data type

boolean

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

HIV seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
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Similar models

Eligibility Leukemia NCT00058799

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00058799
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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