ID

15817

Descripción

Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015); ODM derived from: https://clinicaltrials.gov/show/NCT02428517

Link

https://clinicaltrials.gov/show/NCT02428517

Palabras clave

Versiones (1)
  1. 14/6/16 14/6/16 -
Subido en

14 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Precursor Cell Lymphoblastic Leukemia-Lymphoma NCT02428517

Inglés

Eligibility Precursor Cell Lymphoblastic Leukemia-Lymphoma NCT02428517

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who has been previously diagnosed as one of the following disease;
Descripción

Prior diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332132
acute lymphoblastic leukemia
Descripción

Acute lymphocytic leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023449
biphenotypic acute leukemia with philadelphia-positive chromosome or gene translocation
Descripción

Acute biphenotypic leukemia | Philadelphia chromosome positive | Gene translocation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023464
UMLS CUI [2]
C0856536
UMLS CUI [3]
C1315049
patients whose disease status is one of the following;
Descripción

Disease Status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
first hematologic complete remission (hcr1)
Descripción

complete remission Hematologic First

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0205435
second hematologic complete remission (hcr2)
Descripción

complete remission Hematologic second

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0677874
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0205436
15 years of age and over.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
with a suitable donor (matched sibling, well-matched unrelated, partially-matched unrelated, and haploidentical familial donor)
Descripción

Donor person suitable | Sibling HLA Matched | Unrelated Donor HLA Matched Good | Unrelated Donor HLA Matched Partial | Haploidentical Familial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C3900053
UMLS CUI [2,1]
C0037047
UMLS CUI [2,2]
C1548978
UMLS CUI [3,1]
C3179133
UMLS CUI [3,2]
C1548978
UMLS CUI [3,3]
C0205170
UMLS CUI [4,1]
C3179133
UMLS CUI [4,2]
C1548978
UMLS CUI [4,3]
C0728938
UMLS CUI [5,1]
C3829897
UMLS CUI [5,2]
C0241888
adequate cardiac function (ef>45% via cardiac scan or echocg)
Descripción

Cardiac function | ejection fraction | Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0232174
UMLS CUI [3]
C0013516
european clinical oncology group (ecog) performance status ≥grade 2 or karnofsky scale >60% at the time of screening
Descripción

ECOG performance status | Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
all patients give written informed consent according to guidelines at institution's committee on human research.
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute lymphoblastic leukemia l3 type (burkitt leukemia/lymphoma)
Descripción

L3 adult acute lymphoblastic leukemia | Burkitt Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279591
UMLS CUI [2]
C0006413
biphenotypic acute leukemia without bcr-abl1 translocation
Descripción

Acute biphenotypic leukemia | BCR-ABL1 | translocation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023464
UMLS CUI [2]
C1835417
UMLS CUI [3]
C0040715
lymphoblastic lymphoma (bone marrow blast count is below 20% of mononuclear cells of bone marrow aspirate)
Descripción

Precursor cell lymphoblastic lymphoma | Bone Marrow Blast count procedure | Mononuclear cells Bone marrow

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079748
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0523113
UMLS CUI [3]
C2738404
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Descripción

Mental disorders | Mental deficiency Severe | Compliance behavior Limited | Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0917816
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0439801
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1299582
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Descripción

Breast Feeding | Pregnancy | Childbearing Potential | Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C3831118
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
Descripción

Gender | Contraceptive methods Unwilling | Sexual Abstinence | Contraception, Barrier | Condoms, Male

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
UMLS CUI [3]
C0036899
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0009653
patients with a diagnosis of prior malignancy (including hematologic malignancies such as acute leukemia, lymphoma, multiple myeloma, and myelodysplastic syndrome, etc) unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Descripción

Malignant Neoplasms Previous | Hematologic Neoplasms | Acute leukemia | Lymphoma | Multiple Myeloma | MYELODYSPLASTIC SYNDROME | curative treatment | Skin carcinoma | Carcinoma in Situ | Cervical Intraepithelial Neoplasia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0376545
UMLS CUI [3]
C0085669
UMLS CUI [4]
C0024299
UMLS CUI [5]
C0026764
UMLS CUI [6]
C3463824
UMLS CUI [7]
C1273390
UMLS CUI [8]
C0699893
UMLS CUI [9]
C0007099
UMLS CUI [10]
C0206708
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Similar models

Eligibility Precursor Cell Lymphoblastic Leukemia-Lymphoma NCT02428517

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Prior diagnosis
Item
patients who has been previously diagnosed as one of the following disease;
boolean
C0332132 (UMLS CUI [1])
Acute lymphocytic leukemia
Item
acute lymphoblastic leukemia
boolean
C0023449 (UMLS CUI [1])
Acute biphenotypic leukemia | Philadelphia chromosome positive | Gene translocation
Item
biphenotypic acute leukemia with philadelphia-positive chromosome or gene translocation
boolean
C0023464 (UMLS CUI [1])
C0856536 (UMLS CUI [2])
C1315049 (UMLS CUI [3])
Disease Status
Item
patients whose disease status is one of the following;
boolean
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
complete remission Hematologic First
Item
first hematologic complete remission (hcr1)
boolean
C0677874 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
complete remission Hematologic second
Item
second hematologic complete remission (hcr2)
boolean
C0677874 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
Age
Item
15 years of age and over.
boolean
C0001779 (UMLS CUI [1])
Donor person suitable | Sibling HLA Matched | Unrelated Donor HLA Matched Good | Unrelated Donor HLA Matched Partial | Haploidentical Familial
Item
with a suitable donor (matched sibling, well-matched unrelated, partially-matched unrelated, and haploidentical familial donor)
boolean
C0013018 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0037047 (UMLS CUI [2,1])
C1548978 (UMLS CUI [2,2])
C3179133 (UMLS CUI [3,1])
C1548978 (UMLS CUI [3,2])
C0205170 (UMLS CUI [3,3])
C3179133 (UMLS CUI [4,1])
C1548978 (UMLS CUI [4,2])
C0728938 (UMLS CUI [4,3])
C3829897 (UMLS CUI [5,1])
C0241888 (UMLS CUI [5,2])
Cardiac function | ejection fraction | Echocardiography
Item
adequate cardiac function (ef>45% via cardiac scan or echocg)
boolean
C0232164 (UMLS CUI [1])
C0232174 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
ECOG performance status | Karnofsky Performance Status
Item
european clinical oncology group (ecog) performance status ≥grade 2 or karnofsky scale >60% at the time of screening
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Informed consent
Item
all patients give written informed consent according to guidelines at institution's committee on human research.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
L3 adult acute lymphoblastic leukemia | Burkitt Lymphoma
Item
acute lymphoblastic leukemia l3 type (burkitt leukemia/lymphoma)
boolean
C0279591 (UMLS CUI [1])
C0006413 (UMLS CUI [2])
Acute biphenotypic leukemia | BCR-ABL1 | translocation
Item
biphenotypic acute leukemia without bcr-abl1 translocation
boolean
C0023464 (UMLS CUI [1])
C1835417 (UMLS CUI [2])
C0040715 (UMLS CUI [3])
Precursor cell lymphoblastic lymphoma | Bone Marrow Blast count procedure | Mononuclear cells Bone marrow
Item
lymphoblastic lymphoma (bone marrow blast count is below 20% of mononuclear cells of bone marrow aspirate)
boolean
C0079748 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0523113 (UMLS CUI [2,2])
C2738404 (UMLS CUI [3])
Mental disorders | Mental deficiency Severe | Compliance behavior Limited | Informed Consent Unable
Item
patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
boolean
C0004936 (UMLS CUI [1])
C0917816 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Breast Feeding | Pregnancy | Childbearing Potential | Contraceptive methods Unwilling
Item
nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Gender | Contraceptive methods Unwilling | Sexual Abstinence | Contraception, Barrier | Condoms, Male
Item
male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0009653 (UMLS CUI [5])
Malignant Neoplasms Previous | Hematologic Neoplasms | Acute leukemia | Lymphoma | Multiple Myeloma | MYELODYSPLASTIC SYNDROME | curative treatment | Skin carcinoma | Carcinoma in Situ | Cervical Intraepithelial Neoplasia
Item
patients with a diagnosis of prior malignancy (including hematologic malignancies such as acute leukemia, lymphoma, multiple myeloma, and myelodysplastic syndrome, etc) unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0376545 (UMLS CUI [2])
C0085669 (UMLS CUI [3])
C0024299 (UMLS CUI [4])
C0026764 (UMLS CUI [5])
C3463824 (UMLS CUI [6])
C1273390 (UMLS CUI [7])
C0699893 (UMLS CUI [8])
C0007099 (UMLS CUI [9])
C0206708 (UMLS CUI [10])
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