Eligibility Mantle Cell Lymphoma NCT00737529

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy proven mantle cell lymphoma
Description

Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0334634
patients must have documents relapsed, refractory or pd after treatment with bortezomib
Description

Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
UMLS CUI [4]
C1335499
must have measureable disease on cross sectional imaging by ct
Description

Measurable Disease Cross-sectional imaging CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C3824793
UMLS CUI [1,3]
C0040405
eastern cooperative oncology group (ecog) performance score 0,1 or 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
willing to follow pregnancy precautions
Description

Contraceptive methods Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following laboratory abnormalities
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l)
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 60,000/mm3 (60 x 109/l)
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) > 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma.
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
serum total bilirubin > 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma.
Description

Elevated total bilirubin | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023884
UMLS CUI [3,3]
C1314939
UMLS CUI [3,4]
C0024299
calculated creatinine clearance (cockcroft-gault formula) of < 30 ml /min
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
Description

Patient need for High-dose chemotherapy | Patient need for Allogeneic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1328050
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C2242529
history of active central nervous system (cns) lymphoma within the previous 3 months
Description

Central nervous system lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0742472
subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis
Description

DVT prophylaxis Unwilling | DVT prophylaxis Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0853245
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0853245
UMLS CUI [2,2]
C1299582
prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years
Description

Malignant Neoplasms | Exception Mantle cell lymphoma | Exception Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0334634
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
positive human immunodeficiency virus (hiv) or active hepatitis b or c
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196

Similar models

Eligibility Mantle Cell Lymphoma NCT00737529

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma
Item
biopsy proven mantle cell lymphoma
boolean
C0334634 (UMLS CUI [1])
Bortezomib | Recurrent disease | Refractory Disease | Progressive Disease
Item
patients must have documents relapsed, refractory or pd after treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C1335499 (UMLS CUI [4])
Measurable Disease Cross-sectional imaging CT
Item
must have measureable disease on cross sectional imaging by ct
boolean
C1513041 (UMLS CUI [1,1])
C3824793 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance score 0,1 or 2
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods Willing
Item
willing to follow pregnancy precautions
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Laboratory test result abnormal
Item
any of the following laboratory abnormalities
boolean
C0438215 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 60,000/mm3 (60 x 109/l)
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Exception Liver Involvement with Lymphoma
Item
serum aspartate transaminase/serum glutamic oxaloacetic transaminase(ast/sgot) or alanine transaminase/serum glutamic pyruvic transaminase (alt/sgpt) > 3.0 x upper limit of normal (uln), except in patients with documented liver involvement by lymphoma.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Elevated total bilirubin | Exception Gilbert Disease | Exception Liver Involvement with Lymphoma
Item
serum total bilirubin > 1.5 x uln, except in cases of gilbert's syndrome and documented liver involvement by lymphoma.
boolean
C0741494 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0024299 (UMLS CUI [3,4])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance (cockcroft-gault formula) of < 30 ml /min
boolean
C2711451 (UMLS CUI [1])
Patient need for High-dose chemotherapy | Patient need for Allogeneic Stem Cell Transplantation
Item
patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
boolean
C0686904 (UMLS CUI [1,1])
C1328050 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C2242529 (UMLS CUI [2,2])
Central nervous system lymphoma
Item
history of active central nervous system (cns) lymphoma within the previous 3 months
boolean
C0742472 (UMLS CUI [1])
DVT prophylaxis Unwilling | DVT prophylaxis Unable
Item
subjects not willing or unable to take deep vein thrombosis (dvt) prophylaxis
boolean
C0853245 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0853245 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Mantle cell lymphoma | Exception Disease Free of
Item
prior history of malignancies, other than mcl, unless the patient has been free of the disease for ≥ 3 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0334634 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
positive human immunodeficiency virus (hiv) or active hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])