ID

16180

Beschrijving

Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00098670

Link

https://clinicaltrials.gov/show/NCT00098670

Trefwoorden

Versies (1)
  1. 04-07-16 04-07-16 -
Geüploaded op

4 juli 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

Engels

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
specific diagnosis of b-cell cll
Beschrijving

B-cell chronic lymphocytic leukemia

Datatype

boolean

Alias
UMLS CUI [1]
C0475774
an absolute lymphocytosis of > 5,000/μl
Beschrijving

Lymphocytosis - absolute

Datatype

boolean

Alias
UMLS CUI [1]
C0555108
morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
Beschrijving

Mature Lymphocyte | Prolymphocyte Count

Datatype

boolean

Alias
UMLS CUI [1]
C1513026
UMLS CUI [2]
C2698885
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
Beschrijving

Bone Marrow Examination | Aspirate Unilateral | Biopsy Unilateral | Nucleated cell Lymphoid | Bone Marrow Core biopsy | Infiltration Lymphoid Compatible with Bone Marrow Involvement Chronic Lymphocytic Leukemia | Cellularity Normocellular | Cellularity Hypercellular

Datatype

boolean

Alias
UMLS CUI [1]
C0005957
UMLS CUI [2,1]
C0370199
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0205092
UMLS CUI [4,1]
C1180059
UMLS CUI [4,2]
C1518071
UMLS CUI [5,1]
C0005953
UMLS CUI [5,2]
C1318309
UMLS CUI [6,1]
C0332448
UMLS CUI [6,2]
C1518071
UMLS CUI [6,3]
C0332290
UMLS CUI [6,4]
C1517677
UMLS CUI [6,5]
C0023434
UMLS CUI [7,1]
C0178539
UMLS CUI [7,2]
C0522578
UMLS CUI [8,1]
C0178539
UMLS CUI [8,2]
C0020507
local institution lymphocyte phenotype must reveal a predominant b-cell monoclonal population sharing a b-cell marker (cd19, cd20, cd23) 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
Beschrijving

Lymphocyte Phenotype | B-Lymphocytes monoclonal | B-cell marker | CD19 Antigens | CD20 Antigens | CD23 Antigen | Antigens, CD5 | pan t-cell marker Absent | Immunoglobulin kappa-Chains | Immunoglobulin lambda-Chains | Immunoglobulin level

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C0031437
UMLS CUI [2,1]
C0004561
UMLS CUI [2,2]
C0746619
UMLS CUI [3]
C0443980
UMLS CUI [4]
C0108748
UMLS CUI [5]
C0054946
UMLS CUI [6]
C0123242
UMLS CUI [7]
C0054964
UMLS CUI [8,1]
C0108779
UMLS CUI [8,2]
C0332197
UMLS CUI [9]
C0021036
UMLS CUI [10]
C0021037
UMLS CUI [11]
C0428536
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)
Beschrijving

Intermediate Risk | High risk | Rai Staging System

Datatype

boolean

Alias
UMLS CUI [1]
C3640764
UMLS CUI [2]
C0332167
UMLS CUI [3]
C1514715
patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria:
Beschrijving

Intermediate Risk | Active disease Evidence

Datatype

boolean

Alias
UMLS CUI [1]
C3640764
UMLS CUI [2,1]
C2707252
UMLS CUI [2,2]
C0332120
massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
Beschrijving

splenomegaly massive | Splenomegaly Progressive | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive

Datatype

boolean

Alias
UMLS CUI [1]
C0241231
UMLS CUI [2,1]
C0038002
UMLS CUI [2,2]
C0205329
UMLS CUI [3]
C0744871
UMLS CUI [4,1]
C0019209
UMLS CUI [4,2]
C0205329
UMLS CUI [5]
C0235599
UMLS CUI [6,1]
C0497156
UMLS CUI [6,2]
C0205329
presence of weight loss > 10% over the preceding 6 month period;
Beschrijving

Weight decreased

Datatype

boolean

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

Fatigue

Datatype

boolean

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

Fever | Night sweats | Communicable Diseases Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0015967
UMLS CUI [2]
C0028081
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0332197
progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of less than 6 months
Beschrijving

Lymphocytosis Progressive Increase Period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024282
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0442805
UMLS CUI [1,4]
C1948053
no prior therapy for cll including corticosteroids for autoimmune complications that have developed since the initial diagnosis of cll
Beschrijving

Therapeutic procedure Chronic Lymphocytic Leukemia | Steroid therapy Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0004364
no medical condition requiring chronic use of oral corticosteroids
Beschrijving

medical condition Requirement Adrenal Cortex Hormone Use chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C1524063
UMLS CUI [1,5]
C0205191
performance status 0 - 2
Beschrijving

performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1518965
due to alterations in host immunity, patients with hiv may not be enrolled
Beschrijving

HIV

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
Beschrijving

Pregnancy Due to alemtuzumab Teratogenic effects | Breast Feeding Due to alemtuzumab Teratogenic effects | Females & males of reproductive potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0383429
UMLS CUI [1,4]
C0232910
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0383429
UMLS CUI [2,4]
C0232910
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
creatinine =< 1.5 x upper limit of institutional normal value
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
coomb's testing negative
Beschrijving

Coombs Test Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009961
UMLS CUI [1,2]
C0205160
Terug naar het begin van de pagina

Similar models

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
B-cell chronic lymphocytic leukemia
Item
specific diagnosis of b-cell cll
boolean
C0475774 (UMLS CUI [1])
Lymphocytosis - absolute
Item
an absolute lymphocytosis of > 5,000/μl
boolean
C0555108 (UMLS CUI [1])
Mature Lymphocyte | Prolymphocyte Count
Item
morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
boolean
C1513026 (UMLS CUI [1])
C2698885 (UMLS CUI [2])
Bone Marrow Examination | Aspirate Unilateral | Biopsy Unilateral | Nucleated cell Lymphoid | Bone Marrow Core biopsy | Infiltration Lymphoid Compatible with Bone Marrow Involvement Chronic Lymphocytic Leukemia | Cellularity Normocellular | Cellularity Hypercellular
Item
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
C0005957 (UMLS CUI [1])
C0370199 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C0205092 (UMLS CUI [3,2])
C1180059 (UMLS CUI [4,1])
C1518071 (UMLS CUI [4,2])
C0005953 (UMLS CUI [5,1])
C1318309 (UMLS CUI [5,2])
C0332448 (UMLS CUI [6,1])
C1518071 (UMLS CUI [6,2])
C0332290 (UMLS CUI [6,3])
C1517677 (UMLS CUI [6,4])
C0023434 (UMLS CUI [6,5])
C0178539 (UMLS CUI [7,1])
C0522578 (UMLS CUI [7,2])
C0178539 (UMLS CUI [8,1])
C0020507 (UMLS CUI [8,2])
Lymphocyte Phenotype | B-Lymphocytes monoclonal | B-cell marker | CD19 Antigens | CD20 Antigens | CD23 Antigen | Antigens, CD5 | pan t-cell marker Absent | Immunoglobulin kappa-Chains | Immunoglobulin lambda-Chains | Immunoglobulin level
Item
local institution lymphocyte phenotype must reveal a predominant b-cell monoclonal population sharing a b-cell marker (cd19, cd20, cd23) 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 [1,1])
C0031437 (UMLS CUI [1,2])
C0004561 (UMLS CUI [2,1])
C0746619 (UMLS CUI [2,2])
C0443980 (UMLS CUI [3])
C0108748 (UMLS CUI [4])
C0054946 (UMLS CUI [5])
C0123242 (UMLS CUI [6])
C0054964 (UMLS CUI [7])
C0108779 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0021036 (UMLS CUI [9])
C0021037 (UMLS CUI [10])
C0428536 (UMLS CUI [11])
Intermediate Risk | High risk | Rai Staging System
Item
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)
boolean
C3640764 (UMLS CUI [1])
C0332167 (UMLS CUI [2])
C1514715 (UMLS CUI [3])
Intermediate Risk | Active disease Evidence
Item
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])
C2707252 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
splenomegaly massive | Splenomegaly Progressive | HEPATOMEGALY MASSIVE | Hepatomegaly Progressive | Lymphadenopathy massive | Lymphadenopathy Progressive
Item
massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy;
boolean
C0241231 (UMLS CUI [1])
C0038002 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0744871 (UMLS CUI [3])
C0019209 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0235599 (UMLS CUI [5])
C0497156 (UMLS CUI [6,1])
C0205329 (UMLS CUI [6,2])
Weight decreased
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 | Communicable Diseases Absent
Item
fevers > 100.5°f or night sweats for greater than 2 weeks without evidence of infection;
boolean
C0015967 (UMLS CUI [1])
C0028081 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Lymphocytosis Progressive Increase Period
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 [1,1])
C0205329 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
Therapeutic procedure Chronic Lymphocytic Leukemia | Steroid therapy Autoimmune Diseases
Item
no prior therapy for cll including corticosteroids for autoimmune complications that have developed since the initial diagnosis of cll
boolean
C0087111 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0149783 (UMLS CUI [2,1])
C0004364 (UMLS CUI [2,2])
medical condition Requirement Adrenal Cortex Hormone Use chronic
Item
no medical condition requiring chronic use of oral corticosteroids
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
C0205191 (UMLS CUI [1,5])
performance status
Item
performance status 0 - 2
boolean
C1518965 (UMLS CUI [1])
HIV
Item
due to alterations in host immunity, patients with hiv may not be enrolled
boolean
C0019682 (UMLS CUI [1])
Pregnancy Due to alemtuzumab Teratogenic effects | Breast Feeding Due to alemtuzumab Teratogenic effects | Females & males of reproductive potential Contraceptive methods
Item
due to the unknown teratogenic potential of alemtuzumab, 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 [1,1])
C0678226 (UMLS CUI [1,2])
C0383429 (UMLS CUI [1,3])
C0232910 (UMLS CUI [1,4])
C0006147 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0383429 (UMLS CUI [2,3])
C0232910 (UMLS CUI [2,4])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
creatinine =< 1.5 x upper limit of institutional normal value
boolean
C0201976 (UMLS CUI [1])
Coombs Test Negative
Item
coomb's testing negative
boolean
C0009961 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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