Newly diagnosed large B-cell Lymphoma | Newly diagnosed Burkitt-like lymphoma, Histopathological Grade | Diagnosis confirmed by excisional biopsy | diagnosis confirmed by corde needle biopsy | Materials sufficient for genetic screening for MYC-Rearrangement
Item
1. diffuse large b-cell lymphoma or intermediate ("burkitt-like") lymphoma, newly diagnosed from an excisional biopsy or from a large core biopsy with sufficient diagnostic material to perform genetic testing for myc-r.
boolean
C0079744 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0184921 (UMLS CUI [1,3])
C1368771 (UMLS CUI [2,1])
C1512863 (UMLS CUI [2,2])
C0184921 (UMLS CUI [2,3])
C1518321 (UMLS CUI [2,4])
C0079744 (UMLS CUI [3,1])
C1518321 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
C1368771 (UMLS CUI [4,1])
C1512863 (UMLS CUI [4,2])
C0184921 (UMLS CUI [4,3])
C1318309 (UMLS CUI [4,4])
C0005558 (UMLS CUI [5,1])
C0205410 (UMLS CUI [5,2])
C0807034 (UMLS CUI [5,3])
C0679560 (UMLS CUI [5,4])
MYC-R FISH positive | MYCR-R Cytogenetics positive
Item
2. positivity for myc-r by fluorescent in-situ hybridization (fish) or by classical cytogenetics.
boolean
C0807034 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0752095 (UMLS CUI [2,1])
C0807034 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
Lymphoma prior therapy absent | Exception R-CHOP of 1 Cycle Single Dose | Exception Prednisolon 5 cycles
Item
3. no prior lymphoma treatment, with one exception: one cycle of r-chop regimen is permitted (consisting of one single dose each of rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of prednisone when part of chemotherapy).
boolean
C0024299 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0393023 (UMLS CUI [2,2])
C2045831 (UMLS CUI [2,3])
Prior radiation
Item
4.Prior radiation therapy?
boolean
C1522449 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Age
Item
5. age ≥ 18 years to 70 years of age
boolean
C0001779 (UMLS CUI [1])
Recent CT of neck, chest, abdomen and pelvis | additional medical Imaging in time interval
Item
6. ct imaging of neck, chest, abdomen and pelvis within 28 days prior to registration. any additional imaging used to assess extent of disease must also have been done within 28 days prior to registration
boolean
C0332185 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0027530 (UMLS CUI [1,3])
C0817096 (UMLS CUI [1,4])
C0000726 (UMLS CUI [1,5])
C0030797 (UMLS CUI [1,6])
C1524062 (UMLS CUI [2,1])
C0025086 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0449279 (UMLS CUI [2,4])
Measurable disease, 2-D by diagnostic imaging
Item
7. bidimensionally measurable disease by imaging within 28 days prior to registration
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Bone Marrow Biopsy, sufficient materials, performed within recent time interval.
Item
8. adequate bone marrow biopsy, and aspiration performed for staging within 28 days before registration, and before start of any treatment
boolean
C0005954 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Indication for primary multiagent systemic Chemotherapy
Item
9. indication for primary treatment with systemic multiagent chemotherapy
boolean
C3146298 (UMLS CUI [1,1])
C1883256 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C5205682 (UMLS CUI [1,4])
Creatinine | renal creatinine clearance predicted by Cockroft-Gault formula
Item
10. creatinine ≤ 2.0 mg/dl and estimated (cockroft-gault) creatinine clearance> 50 ml/min within 7 days prior to registration
boolean
C0201975 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C4064204 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Cardiac Ejection frction using MUGA Scan | Cardiac Ejection Fraction using 2D Echocardiogram | EKG with absent abnormal findings
Item
11. cardiac ejection fraction of ≥ 50% by muga scan or by 2-d echocardiogram , as well as ekg without significant abnormality within 28 days prior to registration
boolean
C0232174 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0232174 (UMLS CUI [2,1])
C1317066 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C1623258 (UMLS CUI [3,1])
C2826279 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
ECOG Scale (Performance Status)
Item
12. performance status of 0, of 1, or of 2 (ecog scale)
boolean
C1520224 (UMLS CUI [1])
Willingness to have and maintain a CVL | PICC Line | Double Lumen tunnelled catheter | double lumen subcutaneous venous port system
Item
13. patient willing to have, and to maintain, a central venous line throughout the treatment phase (either picc line, or double lumen tunnelled catheter, or double lumen subcutaneous venous port system)
boolean
C3521108 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2049629 (UMLS CUI [2])
C0441131 (UMLS CUI [3,1])
C0878969 (UMLS CUI [3,2])
C4534545 (UMLS CUI [4,1])
C0441131 (UMLS CUI [4,2])
Clinical study follow up willingness | Clinical study follow up ability
Item
14. willing and logistically able to be followed as outpatient at least twice weekly, during the treatment phase.
boolean
C3274571 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3274571 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Transfusion of blood products, infromed consent
Item
15. signed informed consent to accept transfusion of blood products as medically indicated
boolean
C0005841 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Patient consented to clinical trial
Item
16. signed informed consent to participate in this trial
boolean
C0008976 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Age
Item
1. age > 70 years
boolean
C0001779 (UMLS CUI [1])
Clinical Presentation, Leukemina | Absent disease evidence by medical imaging
Item
2. leukemic presentation, or no evidence of disease by imaging
boolean
C2708283 (UMLS CUI [1,1])
C0023418 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0025086 (UMLS CUI [2,3])
HIV Screening unwillingness | HIV+, combined antiretroviral treatment | CD4-Count, Viral load, exclusion criteria
Item
3. unwilling to be screened for hiv. hiv positive patients must receive combined antiretroviral treatment while on study. they are excluded from participation unless they show a cd4 count >250/ul and a viral load < 50 within 28 days of registration.
boolean
C0459958 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0019699 (UMLS CUI [2,1])
C1963724 (UMLS CUI [2,2])
C0205195 (UMLS CUI [2,3])
C2698595 (UMLS CUI [3,1])
C1168369 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
Total serum bilirubin
Item
4. hepatic involvement and total serum bilirubin ≥ 5 mg/dl within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dl without hepatic involvement within 7 days prior to registration
boolean
C1278039 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
ANC | Platelet count
Item
5. patients with bone marrow involvement and either anc < 1000/ulor platelets < 50,000/ul, within 7 days before registration
boolean
C0948762 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
ANC | Platelet count
Item
6. patients without bone marrow involvement by lymphoma, and either anc < 1500/ul or platelets < 100,000/ul within 7 days before registration
boolean
C0948762 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Myelodysplastic Syndrome | Sickle Cell Disease | Transfusion Dependence
Item
7. patients with myelodysplastic syndrome, with sickle cell disease, or with transfusion dependence for over 6 months antedating the diagnosis of lymphoma.
boolean
C3463824 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0002895 (UMLS CUI [2,1])
C0444921 (UMLS CUI [2,2])
C0005841 (UMLS CUI [3,1])
C0439857 (UMLS CUI [3,2])
C0444921 (UMLS CUI [3,3])
E. Coli-derived proteins; Hypersensitivity
Item
8. known hypersensitivity to e. coli derived proteins
boolean
C0950080 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Reactivation of hepatitis B viral hepatitis; high risk | Hepatitis antiviral therapy; unwilling
Item
9. patients at risk of reactivation of hepatitis b who are unwilling to be treated with appropriate antivirals as medically indicated.
boolean
C2960634 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0280274 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Female; reproductive age; Contraception;Hormonal Contraception; Intrauterine Device; Double Barrier method; Total Abstinence; unwilling
Item
10. pregnant or nursing women, or any patient with reproductive potential and unwilling to use effective contraceptive method from study start to one year after the last dose of protocol therapy. adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Additionl malignancy| prior malignancy; exception; other malignancies; disease free survival interval| exception; BCC; treated | exception; SCC; treated | exception; cervical cancer; in situ
Item
11. additional or prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ~ 5 years
boolean
C0006826 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C0242793 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C0920425 (UMLS CUI [4,3])
C0205411 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C0920425 (UMLS CUI [5,3])
C0205411 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
Transfusion of blood products; unwilling
Item
12. unwilling to receive transfusions of blood products as medically indicated
boolean
C0085430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])