Informations:
Erreur:
ID
43965
Description
Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00004857
Lien
https://clinicaltrials.gov/show/NCT00004857
Mots-clés
Versions (2)
- 19/01/2016 19/01/2016 -
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
Creative Commons BY 4.0
Modèle Commentaires :
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Eligibility Leukemia NCT00004857
Eligibility Leukemia NCT00004857
- StudyEvent: Eligibility
Similar models
Eligibility Leukemia NCT00004857
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
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])
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])
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])
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])
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])
C0009961 (UMLS CUI [2])