Mantle cell lymphoma | Morphology Appropriate | Biopsy sample | CCND1 Positive Immunohistochemistry | t(11;14)(q13;q32) FISH | t(11;14)(q13;q32) PCR | t(11;14)(q13;q32) Karyotyping
Item
patients must have a histologically confirmed diagnosis of mantle cell lymphoma by demonstrating appropriate morphology plus at least one of the following on the biopsy specimen: nuclear cyclin d1+ by immunohistochemistry; t(11;14) by fluorescence in situ hybridization (fish), polymerase chain reaction (pcr), or conventional karyotyping
boolean
C0334634 (UMLS CUI [1])
C0332437 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0677862 (UMLS CUI [3])
C1741716 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0021044 (UMLS CUI [4,3])
C1515705 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
C1515705 (UMLS CUI [6,1])
C0032520 (UMLS CUI [6,2])
C1515705 (UMLS CUI [7,1])
C0022526 (UMLS CUI [7,2])
Prior Chemotherapy Absent Mantle cell lymphoma | Prior Immunotherapy Absent Mantle cell lymphoma | Prior radiation therapy Absent Mantle cell lymphoma | Steroids Course Brief allowed
Item
no prior chemotherapy, immunotherapy or radiotherapy for mantle cell lymphoma; a brief course of steroids (< 14 days) for symptom relief or steroids for other indications are allowed
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0334634 (UMLS CUI [1,3])
C1514461 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0334634 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0334634 (UMLS CUI [3,3])
C0038317 (UMLS CUI [4,1])
C0750729 (UMLS CUI [4,2])
C1879313 (UMLS CUI [4,3])
C0683607 (UMLS CUI [4,4])
Measurable Disease CT scan | PET/CT scan Evaluation
Item
patients must have measurable disease; ct scans at baseline are required to define the extent of measurable disease; the scans must be obtained within 6 weeks prior to registration; combined ct/pet scans may be used for the baseline and subsequent evaluations if accurate tumor measurements can be obtained from the ct component
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1699633 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Absolute neutrophil count | Relationship Bone Marrow Involvement | Relationship Splenomegaly
Item
absolute neutrophil count (anc) > 1500 mm^3 (unless low count due to marrow involvement or splenomegaly)
boolean
C0948762 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0038002 (UMLS CUI [3,2])
Platelet Count measurement | Relationship Bone Marrow Involvement | Relationship Splenomegaly
Item
platelets > 100,000 mm^3 (unless low counts due to marrow involvement or splenomegaly)
boolean
C0032181 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0038002 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
creatinine < 2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Relationship Gilbert Disease | Relationship Liver Involvement with Lymphoma
Item
bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to gilbert's disease or due to liver involvement by lymphoma)
boolean
C1278039 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Age | Left ventricular ejection fraction
Item
patients over the age of 45 must have a left ventricular ejection fraction (lvef) of greater than 45% documented within 90 days prior to registration
boolean
C0001779 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Serum Hepatitis B Surface Antigen Test | Hepatitis B surface antigen positive Requirement Liver Function Tests
Item
patients must be tested for hepatitis b surface antigen (hbs ag) within 4 weeks prior to registration note: hbs ag positive patients are not excluded but will have more stringent monitoring of liver function tests
boolean
C1254699 (UMLS CUI [1])
C0149709 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0023901 (UMLS CUI [2,3])
HIV Infection | Patients At risk Requirement HIV test | Intravenous drug use HIV test | Behavior Risk Increased HIV test | Antiretroviral Therapy, Highly Active
Item
known hiv disease; an hiv test is not required for entry on study but is required if the patient is perceived to be at risk; patients with a history of intravenous drug use or any other behavior with an increased risk for hiv infection should be tested for exposure to the hiv virus; patients with known hiv are excluded since the immunocompromised state of patients with hiv infection or the concomitant use of highly active antiretroviral therapy (haart) may result in more extensive dose modifications than intended for the intensive therapeutic regimen used in this study
boolean
C0019693 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1321876 (UMLS CUI [2,4])
C0699778 (UMLS CUI [3,1])
C1321876 (UMLS CUI [3,2])
C0004927 (UMLS CUI [4,1])
C0035647 (UMLS CUI [4,2])
C0205217 (UMLS CUI [4,3])
C1321876 (UMLS CUI [4,4])
C0887947 (UMLS CUI [5])
Pregnancy | Breast Feeding | Childbearing Potential Hematologic Test | Childbearing Potential Urinalysis | Childbearing Potential Contraceptive methods | Gender Sexually active Contraceptive methods
Item
pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; women of childbearing potential and sexually active males must use an accepted and effective method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0018941 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0042014 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C0700589 (UMLS CUI [6,3])
Peripheral Neuropathy CTCAE Grades
Item
grade 2 or higher baseline peripheral neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hypersensitivity Boron | Mannitol allergy
Item
known hypersensitivity to boron or mannitol
boolean
C0020517 (UMLS CUI [1,1])
C0006030 (UMLS CUI [1,2])
C0571922 (UMLS CUI [2])
Malignant Neoplasms
Item
history of prior malignancy unless at least one of the following conditions are met:
boolean
C0006826 (UMLS CUI [1])
Exception Carcinoma in Situ
Item
malignancy was in-situ
boolean
C1705847 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
Exception Operative Surgical Procedures Malignant Neoplasms | Exception Therapeutic radiology procedure Local Curative Malignant Neoplasms | Exception Disease Free of
Item
malignancy was treated surgically or with local radiation therapy with curative intent and the patient has been disease free for > 3 years
boolean
C1705847 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
C0006826 (UMLS CUI [2,5])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Hormone Therapy Adjuvant To be stopped
Item
any adjuvant hormonal therapy must have been discontinued > 3 months prior to registration
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
Central Nervous System Involvement
Item
known central nervous system (cns) involvement
boolean
C4050309 (UMLS CUI [1])