Diffuse Large B-Cell Lymphoma First Relapse | Status post Complete remission | Less Than Partial response | Partial response First line treatment Diffuse Large B-Cell Lymphoma de novo | Diffuse Large B-Cell Lymphoma Due to Follicular Lymphoma Transformed | Chronic Lymphocytic Leukemia
Item
1. histologically proven diffuse large b-cell lymphoma in first relapse after cr, less than pr or pr to first line treatment de novo dlbcl, dlbcl arising from transformed follicular lymphoma or chronic lymphocytic leukaemia are allowed.
boolean
C0079744 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C0439092 (UMLS CUI [3,1])
C1521726 (UMLS CUI [3,2])
C1521726 (UMLS CUI [4,1])
C1708063 (UMLS CUI [4,2])
C0079744 (UMLS CUI [4,3])
C1515568 (UMLS CUI [4,4])
C0079744 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0024301 (UMLS CUI [5,3])
C0457344 (UMLS CUI [5,4])
C0023434 (UMLS CUI [6])
rituximab | Prior radiation therapy | Autologous hematopoietic stem cell transplant | Relapse CD20 Negative
Item
prior rituximab is allowed prior radiation is allowed prior autologous stem cell transplant is allowed cd20 negative relapses are allowed
boolean
C0393022 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C2193200 (UMLS CUI [3])
C0035020 (UMLS CUI [4,1])
C4527200 (UMLS CUI [4,2])
Age
Item
2. age between 21-70
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. written informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy Minimum
Item
5. minimum life expectancy of 3 months
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Prior Chemotherapy | Anthracyclines | rituximab
Item
6. previously treated with chemotherapy containing anthracyclines and rituximab
boolean
C1514457 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
7. negative urine or serum pregnancy test on females of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence
Item
8. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009907 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
Gender Contraceptive methods
Item
9. male subject agrees to use an acceptable method for contraception for the duration of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Central Nervous System Involvement Absent
Item
10. no cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease CT scan
Item
11. measurable disease on ct scan by international working group response criteria
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Transplantation, Homologous
Item
1. prior allogeneic transplantation
boolean
C0040739 (UMLS CUI [1])
bortezomib
Item
2. prior treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Cancer treatment
Item
3. concomitant use of any other anti-cancer therapy
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
4. concomitant use of any other investigational agent
boolean
C0013230 (UMLS CUI [1])
HIV Infection
Item
5. known infection with human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis B carrier allowed
Item
6. patient has known clinically active hepatitis b (carriers of hepatitis b are permitted to enter the study)
boolean
C0019163 (UMLS CUI [1])
C0262505 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Medical contraindication Chemotherapeutic Agents
Item
7. contraindication to any drug contained in chemotherapy regimens
boolean
C1301624 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
Absence Regimen Containing Anthracyclines
Item
8. not previously treated with anthracycline-containing regimens
boolean
C0332197 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0282564 (UMLS CUI [1,4])
Liver Dysfunction | Renal Insufficiency | Organ dysfunction Interferes with Treatment Protocol | Exception Organ dysfunction caused by Lymphoma
Item
9. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0349410 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0040808 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0349410 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
Few mature neutrophils in the bone marrow | Neutrophil count | Platelet Count measurement | Exception Relationship Bone marrow infiltration
Item
10. poor bone marrow reserve (neutrophils <1.0 x 109/l or platelets <75 x 10(9)/l unless related to bone marrow infiltration
boolean
C2748959 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3854434 (UMLS CUI [4,3])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
11. subject has a calculated or measured creatinine clearance of <20 ml/minute within 14 days before enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia ECG | Conduction system abnormalities | ECG abnormal
Item
12. myocardial infarction within 6 months prior to enrollment or has new york hospital association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0151236 (UMLS CUI [6])
C0522055 (UMLS CUI [7])
Communicable Disease
Item
13. clinically significant active infection
boolean
C0009450 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades | Peripheral Neuropathy with Pain CTCAE Grades
Item
14. subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031117 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0030193 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
15. patients who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Second Cancer | Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
16. coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix)
boolean
C0751623 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Medical condition Preventing Protocol Compliance | Mental condition Preventing Protocol Compliance
Item
17. any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])