ID

30426

Descripción

High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01148173

Link

https://clinicaltrials.gov/show/NCT01148173

Palabras clave

Versiones (2)
  1. 4/6/18 4/6/18 -
  2. 4/6/18 4/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT01148173

Inglés

Eligibility Lymphoma, Non-Hodgkin NCT01148173

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
highly-malignant non-hodgkins-lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
Descripción

Non-Hodgkin Lymphoma High grade | Mantle cell lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C1962917
UMLS CUI [2]
C0334634
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C0432516
cns relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
Descripción

Central Nervous System Relapse meningeal | Central Nervous System Relapse parenchymal | Manifestation of Lymphoma Systemic | Absence Manifestation of Lymphoma Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0277556
UMLS CUI [1,3]
C0521400
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C0277556
UMLS CUI [2,3]
C4277702
UMLS CUI [3,1]
C1280464
UMLS CUI [3,2]
C0024299
UMLS CUI [3,3]
C0205373
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C1280464
UMLS CUI [4,3]
C0024299
UMLS CUI [4,4]
C0205373
ecog performance score ≤2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
no active infection
Descripción

Communicable Disease Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332197
negative hiv-serology
Descripción

Serology negative HIV

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0019682
adequate renal function (creatinine clearance > 50 ml/min)
Descripción

Renal function | Creatinine clearance measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl)
Descripción

Bone Marrow function | Granulocyte count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0857490
UMLS CUI [3]
C0032181
normal bilirubin, ast < 3 x unl
Descripción

Serum bilirubin normal | Aspartate aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0428443
UMLS CUI [2]
C0201899
negative pregnancy test
Descripción

Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427780
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
newly diagnosed nhl with primary cns involvement
Descripción

Non-Hodgkin Lymphoma Central Nervous System Involvement Primary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024305
UMLS CUI [1,2]
C4050309
UMLS CUI [1,3]
C0205225
indolent nhl, lymphoblastic nhl or burkitt lymphoma
Descripción

Indolent Non-Hodgkin Lymphoma | Lymphoblastic NHL | Burkitt Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1334170
UMLS CUI [2]
C0278721
UMLS CUI [3]
C0006413
preceding cns irradiation
Descripción

Irradiation Central Nervous System

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C3714787
pretreatment of cns relapse other than corticosteroids
Descripción

Pre treatment Central Nervous System Relapse | Exception Adrenal Cortex Hormones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2709094
UMLS CUI [1,2]
C3714787
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001617
immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
Descripción

Immunosuppression | Therapeutic immunosuppression | Status post Organ Transplantation | Status post Allogeneic Stem Cell Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021079
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0029216
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C2242529
second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
Descripción

Second Cancer | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
unfit to receive an intensive chemotherapy
Descripción

Medically unfit Chemotherapy intense

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3841806
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0522510
pregnancy or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known intolerance to mtx, ifosfamide, depocyte, cytarabine, thiotepa, carmustine or etoposide
Descripción

Intolerance to Methotrexate | Intolerance to Ifosfamide | Intolerance to DepoCyte | Intolerance to Cytarabine | Intolerance to Thiotepa | Intolerance to Carmustine | Intolerance to Etoposide

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0025677
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0020823
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1517908
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0010711
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0039871
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0007257
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0015133
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT01148173

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Hodgkin Lymphoma High grade | Mantle cell lymphoma | Follicular Lymphoma Ann Arbor lymphoma staging system
Item
highly-malignant non-hodgkins-lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
boolean
C0024305 (UMLS CUI [1,1])
C1962917 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2])
C0024301 (UMLS CUI [3,1])
C0432516 (UMLS CUI [3,2])
Central Nervous System Relapse meningeal | Central Nervous System Relapse parenchymal | Manifestation of Lymphoma Systemic | Absence Manifestation of Lymphoma Systemic
Item
cns relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
boolean
C3714787 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0521400 (UMLS CUI [1,3])
C3714787 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C4277702 (UMLS CUI [2,3])
C1280464 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C1280464 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
C0205373 (UMLS CUI [4,4])
ECOG performance status
Item
ecog performance score ≤2
boolean
C1520224 (UMLS CUI [1])
Communicable Disease Absent
Item
no active infection
boolean
C0009450 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Serology negative HIV
Item
negative hiv-serology
boolean
C0919674 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
Renal function | Creatinine clearance measurement
Item
adequate renal function (creatinine clearance > 50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Bone Marrow function | Granulocyte count | Platelet Count measurement
Item
adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum bilirubin normal | Aspartate aminotransferase measurement
Item
normal bilirubin, ast < 3 x unl
boolean
C0428443 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Pregnancy test negative
Item
negative pregnancy test
boolean
C0427780 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-Hodgkin Lymphoma Central Nervous System Involvement Primary
Item
newly diagnosed nhl with primary cns involvement
boolean
C0024305 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Indolent Non-Hodgkin Lymphoma | Lymphoblastic NHL | Burkitt Lymphoma
Item
indolent nhl, lymphoblastic nhl or burkitt lymphoma
boolean
C1334170 (UMLS CUI [1])
C0278721 (UMLS CUI [2])
C0006413 (UMLS CUI [3])
Irradiation Central Nervous System
Item
preceding cns irradiation
boolean
C1522449 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
Pre treatment Central Nervous System Relapse | Exception Adrenal Cortex Hormones
Item
pretreatment of cns relapse other than corticosteroids
boolean
C2709094 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
Immunosuppression | Therapeutic immunosuppression | Status post Organ Transplantation | Status post Allogeneic Stem Cell Transplantation
Item
immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
boolean
C4048329 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0029216 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C2242529 (UMLS CUI [4,2])
Second Cancer | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix
Item
second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
Medically unfit Chemotherapy intense
Item
unfit to receive an intensive chemotherapy
boolean
C3841806 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intolerance to Methotrexate | Intolerance to Ifosfamide | Intolerance to DepoCyte | Intolerance to Cytarabine | Intolerance to Thiotepa | Intolerance to Carmustine | Intolerance to Etoposide
Item
known intolerance to mtx, ifosfamide, depocyte, cytarabine, thiotepa, carmustine or etoposide
boolean
C1744706 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0020823 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C1517908 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0010711 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0039871 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0007257 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0015133 (UMLS CUI [7,2])
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