Eligibility Chronic Lymphocytic Leukemia NCT00022880

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StudyEvent: Eligibility
1. Eligibility Chronic Lymphocytic Leukemia NCT00022880

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Intermediate-risk b-cell cll or high-risk b-cell cll

Item

patients must fulfill the criteria for the diagnosis of intermediate-risk b-cell cll or high-risk b-cell cll

boolean

C3640764 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])

Nucleated cells on bone marrow aspirate

Item

the bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.

boolean

C1180059 (UMLS CUI [1,1])
C1271729 (UMLS CUI [1,2])

Leukemic lymphocytes: cd20 antigen positivity

Item

patients must have evidence that their leukemic lymphocytes express the cd20 antigen.

boolean

C0054946 (UMLS CUI [1,1])
C1517808 (UMLS CUI [1,2])

Treatment status

Item

patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (cr or partial response [pr]) on, or progressed after completion of last therapy. patients must have received at least one therapy containing a purine nucleoside analogue. patients must not have received more than 4 prior therapies. this includes both chemotherapy and biologic therapy.

boolean

C0392920 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C1704632 (UMLS CUI [3])
C1268902 (UMLS CUI [4])
C2348184 (UMLS CUI [5])

Blood examination

Item

patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (cohort a) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to cll by the investigator, (cohort b) within 14 days of study entry. these blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.

boolean

C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0018928 (UMLS CUI [3])
C0005841 (UMLS CUI [4])

Karnofsky performance status and life expectancy

Item

patients must have a karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.

boolean

C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])

Renal function and liver function

Item

patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [uln]) and hepatic function (defined as total bilirubin <1.5 x uln and ast <3 x uln) within 14 days of study entry. for patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x uln.

boolean

C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Chemotherapy, Immunosuppression and Toxicity

Item

patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within four weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. the prednisone must have been started more than 4 weeks prior to study entry.

boolean

C0392920 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0600688 (UMLS CUI [3])

Radiotherapy

Item

patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.

boolean

C1522449 (UMLS CUI [1])

Cardiac status and comorbidity

Item

patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.

boolean

C1319795 (UMLS CUI [1])
C1319796 (UMLS CUI [2])
C0009488 (UMLS CUI [3])

active obstructive hydronephrosis

Item

patients with active obstructive hydronephrosis.

boolean

C0020295 (UMLS CUI [1])

Further malignancies

Item

patients with prior malignancy other than cll, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.

boolean

C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0242793 (UMLS CUI [3,3])

HIV infection

Item

patients with known hiv infection.

boolean

C0019693 (UMLS CUI [1])

Pregnancy and Contraceptive methods

Item

patients who are pregnant or nursing. patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. males and females must agree to use a contraceptive method from enrollment to 6 months after receiving iodine-131 anti-b1 antibody.

boolean

C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2])
C0700589 (UMLS CUI [3])

Chemotherapy and biologic therapy

Item

patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.

boolean

C0392920 (UMLS CUI [1])
C0005527 (UMLS CUI [2])

Infection requiring intravenous treatment

Item

patients with evidence of active infection requiring intravenous treatment with anti-infectives.

boolean

C0009450 (UMLS CUI [1,1])
C1411942 (UMLS CUI [1,2])

Hama positive

Item

patients known to be hama positive.

boolean

C1291910 (UMLS CUI [1])

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Eligibility Chronic Lymphocytic Leukemia NCT00022880