Eligibility Lymphoma, Mantle-Cell NCT00871546

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StudyEvent: Eligibility
1. Eligibility Lymphoma, Mantle-Cell NCT00871546

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age | Race Any

Item

age >=18 years, either sex, any race.

boolean

C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])

ECOG performance status

Item

eastern cooperative oncology group performance status of 0 or 1.

boolean

C1520224 (UMLS CUI [1])

Hematologic function | Renal function | Liver function | Laboratory Results

Item

adequate hematologic, renal, and hepatic organ function and laboratory parameters.

boolean

C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1254595 (UMLS CUI [4])

Study Subject Mantle cell lymphoma

Item

for subjects with mcl:

boolean

C0681850 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])

Mantle cell lymphoma WHO tumor classification

Item

diagnosis of mcl according to the world health organization (who) criteria.

boolean

C0334634 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])

Chemotherapy Regimen Quantity | Stem cell transplant

Item

received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation..

boolean

C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2])

Measurable Disease | Evaluable Disease

Item

measurable or assessable disease by the revised response criteria for malignant lymphoma.

boolean

C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])

Study Subject Chronic Lymphocytic Leukemia

Item

for subjects with b-cll

boolean

C0681850 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])

Chronic Lymphocytic Leukemia

Item

documented b-cll according to the national cancer institute working group (nci-wg) criteria.

boolean

C0023434 (UMLS CUI [1])

Alkylating Agents | fludarabine | Therapeutic procedure Quantity

Item

received at least one prior alkylating agent-based regimen and one fludarabine-

boolean

C0002073 (UMLS CUI [1])
C0059985 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])

Pentostatin | Prior Therapy Quantity

Item

or pentostatin-containing regimen, but must not have received more than two prior regimens.

boolean

C0030896 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])

Measurable Disease | Evaluable Disease

Item

measurable or assessable disease by nci-wg criteria.

boolean

C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Central Nervous System Involvement Mantle cell lymphoma | Central Nervous System Involvement Chronic Lymphocytic Leukemia

Item

known central nervous system involvement of mcl or b-cll.

boolean

C4050309 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
C4050309 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])

SCH 727965 | Cyclin-Dependent Kinase Inhibitors

Item

previous treatment with sch 727965 or other cyclin-dependent kinase inhibitors.

boolean

C2711996 (UMLS CUI [1])
C1511576 (UMLS CUI [2])

Bortezomib | Study Subject Mantle cell lymphoma

Item

for mcl, previous treatment with bortezomib.

boolean

C1176309 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0334634 (UMLS CUI [2,2])

Alemtuzumab | Study Subject Chronic Lymphocytic Leukemia

Item

for b-cll, previous treatment with alemtuzumab.

boolean

C0383429 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])

HIV Infection

Item

known hiv infection.

boolean

C0019693 (UMLS CUI [1])

Hepatitis B | Hepatitis C

Item

known active hepatitis b or c.

boolean

C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])

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Eligibility Lymphoma, Mantle-Cell NCT00871546