ID

43965

Description

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

Keywords

Versions (2)
  1. 1/19/16 1/19/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00004857

English

Eligibility Leukemia NCT00004857

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004857
Criteria
Description

Criteria

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

lymphocyte count

Data type

boolean

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

prolymphocytes

Data type

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.
Description

bone marrow

Data type

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.
Description

lymphocytes

Data type

boolean

Alias
UMLS CUI [1]
C0024264
1.2 staging
Description

staging

Data type

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.
Description

rai staging system

Data type

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:
Description

intermediate-risk group

Data type

boolean

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

splenomegaly, lymphadenopathy

Data type

boolean

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

weight loss

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°c or night sweats for greater than 2 weeks without evidence of infection
Description

fever, night sweats

Data type

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.
Description

lymphocytosis

Data type

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.
Description

therapy

Data type

boolean

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

steroids

Data type

boolean

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

age

Data type

boolean

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

performance status

Data type

boolean

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

hiv

Data type

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.
Description

pregnancy, lactation, contraception

Data type

boolean

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

laboratory

Data type

boolean

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

creatinine, coomb's test

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0009961
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Similar models

Eligibility Leukemia NCT00004857

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00004857
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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