Informed Consent
Item
1. voluntary written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male or female subject 18 years of age and older
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status | ECOG performance status
Item
3. karnofsky performance status (kps) score of 50%. ecog performance status score greater than 2.
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone B-Cell Lymphoma | Mantle cell lymphoma
Item
4. histologically confirmed follicular grade 1-3a, marginal zone or mantle cell nhl.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1367654 (UMLS CUI [2])
C0334634 (UMLS CUI [3])
Recurrent disease | Progressive Disease | Prior Chemotherapy Quantity | Treatment required
Item
5. relapsed or progressive disease after at least 1 prior chemotherapy requiring treatment.
boolean
C0277556 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C1514457 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332121 (UMLS CUI [4])
Measurable Disease 2-Dimensional | Lesion size Linear | Lesion Quantity
Item
6. bi-dimensionally measurable disease with at least 1 lesion 2 cm in a single dimension
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Hematologic function parameters | Liver function parameters | Renal function parameters
Item
7. hematologic, hepatic, and renal function parameters.
boolean
C0221130 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0449381 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0449381 (UMLS CUI [3,2])
Toxicity Patient recovered | Prior surgery | Therapeutic radiology procedure | Chemotherapy | Biological treatment | Autologous bone marrow transplant | Autologous hematopoietic stem cell transplant | Investigational New Drugs
Item
8. recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous bone marrow or stem cell transplant, or investigational drugs
boolean
C0600688 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
C0455610 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
C0194037 (UMLS CUI [6])
C2193200 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Life Expectancy
Item
9. expected survival of 3 months
boolean
C0023671 (UMLS CUI [1])
Contraceptive methods
Item
10. accepted birth control methods during treatment and for 12 months after completion of treatment.
boolean
C0700589 (UMLS CUI [1])
Follicular Lymphoma Ann Arbor lymphoma staging system
Item
1. follicular lymphoma grade 3b
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Analogue | Hypersensitivity Murine protein | Hypersensitivity Drug Formulation Excipient
Item
2. history of allergy to any of the study medications, their analogues, murine proteins, or excipients in the various formulations
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0243071 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C1699668 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0524527 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Peripheral Neuropathy CTCAE Grades | Peripheral Neuropathy Clinical examination
Item
3. grade 2 peripheral neuropathy or clinical examination within 14 days before enrollment
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031117 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
4. serum creatinine 2.5 mg/dl within 14 days before enrollment.
boolean
C0201976 (UMLS CUI [1])
Absolute neutrophil count | Platelet Count measurement
Item
5. absolute neutrophil count (anc) < 1,000/l, platelet count < 70,000/l within 14 days before enrollment
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin
Item
6. aspartate transaminase (ast [sgot]) and alanine transaminase (alt/sgpt]) > 2 x the upper limit of normal (uln), total bilirubin > 3 uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0741494 (UMLS CUI [3])
Unresponsive to Rituxan | Unresponsive to Radioimmunotherapy Against CD20 Antigens
Item
7. rituxan refractory or refractory to anti-cd20 radioimmunotherapy (no response to prior rituxan or prior rituxan-containing regimen, or a response with a ttp of less than 6 months)
boolean
C0205269 (UMLS CUI [1,1])
C0732355 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0085101 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0054946 (UMLS CUI [2,4])
Therapeutic radiology procedure Malignant Neoplasms | Biological treatment Malignant Neoplasms | Chemotherapy Malignant Neoplasms | Nitrosourea | Mitomycin
Item
8. cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks prior to study day 1 (6 weeks if nitrosurea or mytomycin-c)
boolean
C1522449 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0028210 (UMLS CUI [4])
C0002475 (UMLS CUI [5])
Vaccine Therapy Previous Lymphoma
Item
9. prior lymphoma vaccine therapy within 12 months to study day 1
boolean
C0042209 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0024299 (UMLS CUI [1,3])
Antibody therapy Lymphoma | Radioimmunotherapy
Item
10. prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to study day 1
boolean
C0281176 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
C0085101 (UMLS CUI [2])
Autologous bone marrow transplant | Autologous hematopoietic stem cell transplant
Item
11. autologous bone marrow or stem cell transplant within 6 months prior to study day 1
boolean
C0194037 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
Hepatitis | Liver disease
Item
12. known history of hepatitis or hepatic disease.
boolean
C0019158 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Central nervous system lymphoma
Item
13. presence of central nervous system (cns) lymphoma
boolean
C0742472 (UMLS CUI [1])
HIV Infection | AIDS
Item
14. known history of hiv infection or aids
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
Transformation Histologic | Follicular Lymphoma Diffuse Large B-Cell Lymphoma | Marginal Zone B-Cell Lymphoma Diffuse Large B-Cell Lymphoma
Item
15. histologic transformation (follicular or marginal zone to diffuse large b cell lymphoma [dlbcl]
boolean
C3714584 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0024301 (UMLS CUI [2,1])
C0079744 (UMLS CUI [2,2])
C1367654 (UMLS CUI [3,1])
C0079744 (UMLS CUI [3,2])
Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma
Item
16. presence of pleural or peritoneal effusion with positive cytology for lymphoma
boolean
C0032227 (UMLS CUI [1])
C0003964 (UMLS CUI [2])
C3846509 (UMLS CUI [3,1])
C0024299 (UMLS CUI [3,2])
Primary tumor Other Treatment required for
Item
17. another primary malignancy requiring active treatment
boolean
C0677930 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Disease Serious | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Completion of clinical trial | Mental condition compromises Completion of clinical trial
Item
18. serious non-malignant disease (e.g., congestive heart failure [chf], hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions (including psychiatric), which would compromise protocol objectives n the opinion of the investigator and/or sponsor
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0020295 (UMLS CUI [3])
C0004623 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042769 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0026946 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C2945640 (UMLS CUI [8,2])
C2732579 (UMLS CUI [8,3])
Heart Disease New York Heart Association Classification
Item
19. new york heart association class iii or iv (appendix d) cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Major surgery | Exception Operative Surgical Procedure Diagnostic
Item
20. major surgery, other than diagnostic surgery, within 4 weeks prior to study day 1
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0348026 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
21. female subject who is pregnant or currently breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
22. received other investigational drugs with 14 days before enrollment
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Bortezomib | Pentostatin allergy | Hypersensitivity Rituximab | Hypersensitivity Boron | Mannitol allergy
Item
23. hypersensitivity to bortezomib, pentostatin, rituximab, boron or mannitol.
boolean
C0020517 (UMLS CUI [1,1])
C1176309 (UMLS CUI [1,2])
C0570696 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0393022 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0006030 (UMLS CUI [4,2])
C0571922 (UMLS CUI [5])