ID

16180

Description

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

Keywords

Versions (1)
  1. 7/4/16 7/4/16 -
Uploaded on

July 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

English

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

B-cell chronic lymphocytic leukemia

Data type

boolean

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

Lymphocytosis - absolute

Data type

boolean

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

Mature Lymphocyte | Prolymphocyte Count

Data type

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
Description

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

Data type

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
Description

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

Data type

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)
Description

Intermediate Risk | High risk | Rai Staging System

Data type

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:
Description

Intermediate Risk | Active disease Evidence

Data type

boolean

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

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

Data type

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;
Description

Weight decreased

Data type

boolean

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

Fatigue

Data type

boolean

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

Fever | Night sweats | Communicable Diseases Absent

Data type

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
Description

Lymphocytosis Progressive Increase Period

Data type

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
Description

Therapeutic procedure Chronic Lymphocytic Leukemia | Steroid therapy Autoimmune Diseases

Data type

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
Description

medical condition Requirement Adrenal Cortex Hormone Use chronic

Data type

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
Description

performance status

Data type

boolean

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

HIV

Data type

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
Description

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

Data type

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
Description

Creatinine measurement, serum

Data type

boolean

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

Coombs Test Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0009961
UMLS CUI [1,2]
C0205160
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Similar models

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00098670

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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