ID

12899

Description

Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00136422

Lien

https://clinicaltrials.gov/show/NCT00136422

Mots-clés

Versions (1)
  1. 05/01/2016 05/01/2016 -
Téléchargé le

5 janvier 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Acute Myelogenous Leukemia NCT00136422

Anglais

Eligibility Acute Myelogenous Leukemia NCT00136422

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have pathologically documented myelodysplasia or acute myelogenous leukemia.
Description

myelodysplastic syndrome, myeloid leukemia

Type de données

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023467
the patients with myelodysplasia must also have: french-american-british (fab) subtype refractory anemia with excess blasts (raeb) or refractory anemia with excess blasts in transformation (raeb-t), or normal or hypercellular bone marrow.
Description

inclusion myelodysplastic syndrome

Type de données

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C1512693
UMLS CUI [2]
C2984084
UMLS CUI [3]
C0005953
the patients with acute myelogenous leukemia must also: not be candidates for myelosuppressive chemotherapy due to age or comorbid disease, or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 60 days
Description

inclusion acute myelogenous leukemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C1512693
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0277556
UMLS CUI [4]
C0205269
eastern cooperative oncology group (ecog) performance status 0 or 1.
Description

ecog performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
estimated life expectancy of 6 months or greater.
Description

life expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
age at least 18 years.
Description

age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal therapy allowed).
Description

therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0087111
greater than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (dli).
Description

stem cell transplant, dli

Type de données

boolean

Alias
UMLS CUI [1]
C1504389
UMLS CUI [2]
C1512034
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled active infection.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0517627
pregnancy or nursing mothers.
Description

pregnancy, breastfeeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous participation in an adenovirus based trial.
Description

study subject participation status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
the patients with myelodysplasia who have either: fab subtype refractory anemia (ra), refractory anemia with ringed sideroblasts (rars), chronic myelomonocytic leukemia (cmml), or the presence of hypocellular bone marrow.
Description

exclusion myelodysplastic syndrome

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3463824
UMLS CUI [2]
C2984084
UMLS CUI [3]
C0005953
chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy within the last 4 weeks.
Description

therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0038317
active central nervous system (cns) disease.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007682
evidence of infection with the human immunodeficiency virus.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0019682
active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.
Description

comorbidity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0004936
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Similar models

Eligibility Acute Myelogenous Leukemia NCT00136422

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
myelodysplastic syndrome, myeloid leukemia
Item
patients must have pathologically documented myelodysplasia or acute myelogenous leukemia.
boolean
C3463824 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
inclusion myelodysplastic syndrome
Item
the patients with myelodysplasia must also have: french-american-british (fab) subtype refractory anemia with excess blasts (raeb) or refractory anemia with excess blasts in transformation (raeb-t), or normal or hypercellular bone marrow.
boolean
C3463824 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C2984084 (UMLS CUI [2])
C0005953 (UMLS CUI [3])
inclusion acute myelogenous leukemia
Item
the patients with acute myelogenous leukemia must also: not be candidates for myelosuppressive chemotherapy due to age or comorbid disease, or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 60 days
boolean
C0023467 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
ecog performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
estimated life expectancy of 6 months or greater.
boolean
C0023671 (UMLS CUI [1])
age
Item
age at least 18 years.
boolean
C0001779 (UMLS CUI [1])
therapy
Item
greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal therapy allowed).
boolean
C0087111 (UMLS CUI [1])
stem cell transplant, dli
Item
greater than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (dli).
boolean
C1504389 (UMLS CUI [1])
C1512034 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
uncontrolled active infection.
boolean
C0009488 (UMLS CUI [1,1])
C0517627 (UMLS CUI [1,2])
pregnancy, breastfeeding
Item
pregnancy or nursing mothers.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
study subject participation status
Item
previous participation in an adenovirus based trial.
boolean
C2348568 (UMLS CUI [1])
exclusion myelodysplastic syndrome
Item
the patients with myelodysplasia who have either: fab subtype refractory anemia (ra), refractory anemia with ringed sideroblasts (rars), chronic myelomonocytic leukemia (cmml), or the presence of hypocellular bone marrow.
boolean
C0680251 (UMLS CUI [1,1])
C3463824 (UMLS CUI [1,2])
C2984084 (UMLS CUI [2])
C0005953 (UMLS CUI [3])
therapy
Item
chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy within the last 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
comorbidity
Item
active central nervous system (cns) disease.
boolean
C0009488 (UMLS CUI [1,1])
C0007682 (UMLS CUI [1,2])
comorbidity
Item
evidence of infection with the human immunodeficiency virus.
boolean
C0009488 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
comorbidity
Item
active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.
boolean
C0009488 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
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