ID

43965

Descripción

Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00004857

Link

https://clinicaltrials.gov/show/NCT00004857

Palabras clave

Versiones (2)
  1. 19/1/16 19/1/16 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Leukemia NCT00004857

Inglés

Eligibility Leukemia NCT00004857

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004857
Criteria
Descripción

Criteria

1.1 an absolute lymphocytosis of > 5,000/µl
Descripción

lymphocyte count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200635
1.1.1 morphologically, the lymphocytes must appear mature with < 55% prolymphocytes.
Descripción

prolymphocytes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2698885
1.1.2 bone marrow examination must include at least a unilateral aspirate and biopsy. the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by cll. the overall cellularity must be normocellular or hypercellular.
Descripción

bone marrow

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0370199
1.1.3 local institution lymphocyte phenotype must reveal a predominant b-cell monoclonal population sharing a b-cell marker (cd19, cd20, cd23, cd24) with the cd5 antigen, in the absence of other pan-t-cell markers. additionally, the b-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density. patients with bright surface immunoglobulin levels must have cd23 co-expression.
Descripción

lymphocytes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024264
1.2 staging
Descripción

staging

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0699749
1.2.1 patients must be in the intermediate- or high-risk categories of the modified three-stage rai staging system (i.e., stages i, ii, iii, or iv) per the protocol.
Descripción

rai staging system

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514715
1.2.2 patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
Descripción

intermediate-risk group

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3640764
massive or progressive splenomegaly and/or lymphadenopathy
Descripción

splenomegaly, lymphadenopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038002
UMLS CUI [2]
C0497156
presence of weight loss > 10% over the preceding 6 month period;
Descripción

weight loss

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1262477
grade 2 or 3 fatigue
Descripción

fatigue

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015672
fevers > 100.5°c or night sweats for greater than 2 weeks without evidence of infection
Descripción

fever, night sweats

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C0028081
progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months.
Descripción

lymphocytosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024282
2. prior treatment: no prior therapy for cll including corticosteroids for autoimmune complications that have developed since the initial diagnosis of cll.
Descripción

therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
3. no medical condition requiring chronic use of oral corticosteroids.
Descripción

steroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038317
4. age ≥18 years.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
5. performance status 0 - 2.
Descripción

performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
6. no hiv disease. due to alterations in host immunity, patients with hiv may not be enrolled.
Descripción

hiv

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
7. non-pregnant and non-nursing. due to the unknown teratogenic potential of campath-1h, pregnant or nursing women may not be enrolled. women and men of reproductive potential should agree to use an effective means of birth control.
Descripción

pregnancy, lactation, contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
8. initial required laboratory values:
Descripción

laboratory

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0681902
creatinine <1.5 x upper limit of institutional normal value coomb's testing negative
Descripción

creatinine, coomb's test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0009961
Volver a la parte superior de la página

Similar models

Eligibility Leukemia NCT00004857

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004857
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
lymphocyte count
Item
1.1 an absolute lymphocytosis of > 5,000/µl
boolean
C0200635 (UMLS CUI [1])
prolymphocytes
Item
1.1.1 morphologically, the lymphocytes must appear mature with < 55% prolymphocytes.
boolean
C2698885 (UMLS CUI [1])
bone marrow
Item
1.1.2 bone marrow examination must include at least a unilateral aspirate and biopsy. the aspirate smear must show > 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by cll. the overall cellularity must be normocellular or hypercellular.
boolean
C0005953 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0370199 (UMLS CUI [2,2])
lymphocytes
Item
1.1.3 local institution lymphocyte phenotype must reveal a predominant b-cell monoclonal population sharing a b-cell marker (cd19, cd20, cd23, cd24) with the cd5 antigen, in the absence of other pan-t-cell markers. additionally, the b-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density. patients with bright surface immunoglobulin levels must have cd23 co-expression.
boolean
C0024264 (UMLS CUI [1])
staging
Item
1.2 staging
boolean
C0699749 (UMLS CUI [1])
rai staging system
Item
1.2.1 patients must be in the intermediate- or high-risk categories of the modified three-stage rai staging system (i.e., stages i, ii, iii, or iv) per the protocol.
boolean
C1514715 (UMLS CUI [1])
intermediate-risk group
Item
1.2.2 patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
boolean
C3640764 (UMLS CUI [1])
splenomegaly, lymphadenopathy
Item
massive or progressive splenomegaly and/or lymphadenopathy
boolean
C0038002 (UMLS CUI [1])
C0497156 (UMLS CUI [2])
weight loss
Item
presence of weight loss > 10% over the preceding 6 month period;
boolean
C1262477 (UMLS CUI [1])
fatigue
Item
grade 2 or 3 fatigue
boolean
C0015672 (UMLS CUI [1])
fever, night sweats
Item
fevers > 100.5°c or night sweats for greater than 2 weeks without evidence of infection
boolean
C0015967 (UMLS CUI [1])
C0028081 (UMLS CUI [2])
lymphocytosis
Item
progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months.
boolean
C0024282 (UMLS CUI [1])
therapy
Item
2. prior treatment: no prior therapy for cll including corticosteroids for autoimmune complications that have developed since the initial diagnosis of cll.
boolean
C0087111 (UMLS CUI [1])
steroids
Item
3. no medical condition requiring chronic use of oral corticosteroids.
boolean
C0038317 (UMLS CUI [1])
age
Item
4. age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
performance status
Item
5. performance status 0 - 2.
boolean
C1520224 (UMLS CUI [1])
hiv
Item
6. no hiv disease. due to alterations in host immunity, patients with hiv may not be enrolled.
boolean
C0019682 (UMLS CUI [1])
pregnancy, lactation, contraception
Item
7. non-pregnant and non-nursing. due to the unknown teratogenic potential of campath-1h, pregnant or nursing women may not be enrolled. women and men of reproductive potential should agree to use an effective means of birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
laboratory
Item
8. initial required laboratory values:
boolean
C0681902 (UMLS CUI [1])
creatinine, coomb's test
Item
creatinine <1.5 x upper limit of institutional normal value coomb's testing negative
boolean
C0201976 (UMLS CUI [1])
C0009961 (UMLS CUI [2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial