Eligibility Leukemia NCT00004857

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StudyEvent: Eligibility
1. Eligibility Leukemia NCT00004857

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Criteria

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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Eligibility Leukemia NCT00004857