natgillin/translations-raw huggingface dataset:
receiving Zevalin as consolidation after remission induction with platelet counts < 150,000/ mm3
bolniki, ki dobivajo Zevalin kot konsolidacijsko terapijo za utrjevanje odgovora, ki je bil dosežen z indukcijskim zdravljenjem in imajo število trombocitov < 150. 000/ mm3 bolniki s številom nevtrofilnih celic < 1. 500/ mm3,
- patients with neutrophil counts < 1,500/ mm3,
-
- patients who have received prior bone marrow transplant or stem cell support,
- bolniki s predhodno presaditvijo kostnega mozga ali podporo matičnih celic,
- children and adolescents under 18 years of age.
- otroci in mladostniki mlajši od 18 let.
Patients should not receive growth factor treatment such as G-CSF for 2 weeks prior to Zevalin treatment as well as for 2 weeks following completion of the regimen because of the potential sensitivity of rapidly dividing myeloid cells to radiation.
G- CSF) 2 tedna pred zdravljenjem z zdravilom Zevalin in še 2 tedna po končanem zdravljenju.
Special caution is required with respect to bone marrow depletion.
Izčrpanje kostnega mozga zahteva posebno pozornost.
Patients who had received murine-derived proteins before Zevalin treatment, should be tested for human anti-mouse antibodies (HAMA).
Bolnike, ki so pred zdravljenjem z Zevalinom prejemali mišje beljakovine, je treba testirati na prisotnost človeških protiteles proti mišjemu antigenu (HAMA- human anti- mouse antibodies).
Patients who have developed HAMA may have allergic or hypersensitivity reactions when treated with Zevalin or other murine-derived proteins.
Pri bolnikih, ki so razvili HAMA, se lahko pri zdravljenju z Zevalinom ali drugimi beljakovinami mišjega porekla pojavijo alergijske ali preobčutljivostne reakcije.
Severe infusion reactions may occur during or following rituximab infusion, which may be associated with chest pain, cardiogenic shock, myocardial infarction, pulmonary edema, ventricular fibrillation, apnea, bronchospasm, dyspnea, hypoxia, angioneurotic edema, flushing, hypotension, ARDS, and lung infiltration.
Med ali po infuziji rituksimaba lahko pride do resne reakcije na infuzijo, ob kateri se lahko pojavijo bolečine v prsnem košu, kardiogeni šok, infarkt miokarda, pljučni edem, prekatna fibrilacija, prekinitev dihanja, bronhospazem, oteženo dihanje, hipoksija, angioedem, zardevanje, padec krvnega tlaka, ARDS in prizadetost pljuč.
Infusion– related reactions due to Zevalin are less common and less severe.
Reakcije na infuzijo Zevalina so manj pogoste in manj hude.
4 Anaphylactic and other hypersensitivity reactions have been reported in fewer than 1% of patients following the intravenous administration of proteins to patients.
V primeru, da bi med aplikacijo rituksimaba in z [90Y] označenega
Medicinal products for the treatment of hypersensitivity reactions, e. g. adrenaline, antihistamines and corticosteroids, should be available for immediate use in the event of an allergic reaction during administration of rituximab and radiolabelled Zevalin.
4 Zevalina prišlo do alergijske reakcije, morajo biti takoj na razpolago zdravila za zdravljenje preobčutljivostnih reakcij, npr. adrenalin, antihistaminiki in kortikosteroidi.
After use of Zevalin, patients should generally be tested for HAMA before any further treatment with mouse derived proteins.
Na splošno bi morali biti po uporabi Zevalina bolniki pred prejemom kakršnega koli nadaljnjega zdravljenja z zdravili na osnovi mišjih beljakovin testirani na prisotnost HAMA.
Severe mucocutaneous reactions, including Stevens-Johnson Syndrome with fatal outcome, have rarely been reported in association with the Zevalin therapeutic regimen, which includes rituximab and radiolabelled Zevalin.
Redko so poročali, da je bilo zdravljenje z zdravilom Zevalin, ki je vključevalo rituksimab in z [90Y] označeni Zevalin, povezano s pojavom hudih reakcij kože in sluznic, vključno s Stevens- Johnsonovim sindromom, ki se je končal s smrtnim izidom.
Patients experiencing a mucocutaneous reaction should not receive any further component of the Zevalin regimen.
Pri bolnikih, ki so imeli mukokutano reakcijo, se mora prekiniti dajanje katerekoli zdravilne učinkovine, ki se uporablja v pri režimu zdravljenja z zdravilom Zevalin.
Long-term animal studies on the effect on fertility and reproductive function have not been performed.
Dolgoročnih študij učinka na plodnost in reproduktivno funkcijo pri živalih niso izvajali.
Due to the nature of the compound, females of child-bearing potential, as well as males, should use effective contraceptive measures during treatment with Zevalin and for 12 months afterwards.
Glede na naravo zdravilne učinkovine morajo ženske v rodni dobi, enako pa tudi moški, med zdravljenjem z Zevalinom in še 12 mesecev po tem, uporabljati učinkovito kontracepcijsko zaščito.
The safety of immunisation with any vaccine, particularly live viral vaccines, following therapy with Zevalin has not been studied.
Varnosti imunizacije s katerim koli cepivom, zlasti z živimi virusnimi vakcinami, po terapiji z Zevalinom niso raziskovali.
The ability to generate a primary or anamnestic humoral response to any vaccine has also not been studied.
Sposobnosti generiranja primarnega ali anamnestičnega humoralnega odgovora na katero koli vakcino niso proučevali.
No data are available on patients with CNS-lymphoma as those patients were not included in clinical studies.
Na voljo ni podatkov o bolnikih z CNS limfomom, ker ti bolniki niso bili vključeni v klinične študije.
Close monitoring for evidence of extravasation during the injection of Zevalin is required in order to avoid radiation-associated tissue damage.
Z namenom izogniti se poškodbi tkiva zaradi ionizirajočega sevanja je med injiciranjem zdravila Zevalin zahtevano skrbno spremljanje pojava ekstravazacije.
If any signs or symptoms of extravasation have occurred,, the infusion should be immediately terminated and restarted in another vein.
Če se pojavi kakršenkoli znak ali simptom ekstravazacije, je treba infundiranje takoj ustaviti in ga ponovno začeti v drugi veni.
Since IgG is known to pass the placenta and because of the concomitant use of radiation, Zevalin must not be used during pregnancy.
Ker je znano, da IgG prehaja skozi placento, obenem pa tudi zaradi sočasne uporabe ionizirajočega sevanja, se Zevalin med nosečnostjo ne sme uporabljati.
Females of childbearing potential as well as males should use effective contraceptive methods during treatment with Zevalin and for 12 months afterwards.
Ženske v rodni dobi, enako pa tudi moški, morajo med zdravljenjem z Zevalinom in še 12 mesecev po tem uporabljati učinkovito kontracepcijsko zaščito.
When it is necessary to administer Zevalin to women of childbearing potential, information should always be sought about pregnancy.
Kadar je potrebno aplicirati Zevalin ženskam v rodni dobi, je treba vselej preveriti stanje glede morebitne nosečnosti.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise and alternative therapies which do not involve ionising radiation should be then considered.
Vsako žensko, ki ji je izostala menstruacija, moramo obravnavati kot da je noseča, dokler se ne dokaže nasprotno, upoštevati pa je treba možnosti drugačnih načinov zdravljenja, pri katerih ni ionizirajočega sevanja.
It is not known whether ibritumomab tiuxetan is excreted in human milk.
Ni znano, ali se ibritumomab tiuksetan pri ljudeh izloča v materino mleko.
Because human IgG is excreted in human milk and because the potential for absorption and immunosuppression in the infant is unknown, women must discontinue breast-feeding.
Ker se človeški IgG izloča v materino mleko in ker absorpcijski in imunosupresijski potencial pri dojenčkih nista znana, morajo ženske med zdravljenjem prenehati z dojenjem.
The radiation dose resulting from therapeutic exposure may result in secondary malignancies and in development of hereditary defects.
Odmerek sevanja zaradi terapevtske izpostavljenosti ima lahko za posledico pojav sekundarnih malignih obolenj in razvoj genetskih okvar.
It is necessary to ensure that the risks of the radiation are less than from the disease itself.
V vseh primerih je potrebno zagotoviti, da je tveganje zaradi sevanja manj ogrožajoče kot bolezen sama.
The majority of patients may be expected to experience adverse reactions.
Pri večini bolnikov lahko pričakujemo pojav neželenih učinkov.
The frequencies of the adverse reactions reported below (very common ≥ 1/ 10, common ≥ 1/ 100 to < 1/ 10, uncommon ≥ 1/ 1,000 to < 1/ 100, rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare: < 1/ 10,000) are based on clinical trial data.
5 Pogostnost neželenih učinkov, ki so navedeni v nadaljevanju (zelo pogosti: ≥ 1/ 10, pogosti: ≥ 1/ 100 do 1/ 10, občasni: ≥ 1/ 1. 000 do < 1/ 100, redki: ≥ 1/ 10. 000 do < 1/ 1. 000; zelo redki: < 1/ 10. 000) temelji na podatkih kliničnih študij.
Adverse drug reactions deriving from post-marketing experience are described separately.
Neželeni učinki, ugotovljeni na podlagi postmarketinških izkušenj, so opisani posebej.
The adverse drug reactions are at least possibly related to the Zevalin therapeutic regimen which includes rituximab and radiolabelled Zevalin.
Ti neželeni učinki bi bili morda lahko povezani z zdravljenjem z zdravilom Zevalin, ki vključuje rituksimab in z [90Y] označeni Zevalin.
Anaphylactic reactions and hypersensitivity Anaphylactic and other hypersensitivity reactions have been reported in fewer than 1% of patients following the intravenous administration of proteins to patients.
Anafilaktične in preobčutljivostne reakcije Pri manj kot 1% bolnikov po intravenski aplikaciji beljakovin so poročali o pojavu anafilakse in drugih preobčutljivostnih reakcij.
Medicinal products for the treatment of hypersensitivity reactions, e. g. adrenaline, antihistamines and corticosteroids, should be available for immediate use in the event of an allergic reaction during administration of Zevalin.
V primeru, da bi med aplikacijo Zevalina prišlo do alergijske reakcije, morajo biti takoj na razpolago zdravila za zdravljenje preobčutljivostnih reakcij, npr. adrenalin, antihistaminiki in kortikosteroidi.
Haematological adverse reactions Haematological toxicity has been very commonly observed in clinical trials, and is dose-limiting.
Hematološki neželeni učinki V kliničnih študijah je pogosto opisana hematološka toksičnost, zaradi katere je potrebno omejiti odmerjanje.
Median time to blood platelet and granulocyte nadirs were around 60 days after start of treatment.
Mediani čas do doseženih najvišjih vrednosti v številu trombocitov in granulocitov je bil približno 60 dni od začetka zdravljenja.
In clinical trials with the indication of relapsed and refractory NHL, Grade 3 or 4 thrombocytopenia was reported with median times to recovery of 13 and 21 days and grade 3 or 4 neutropenia with median times to recovery of 8 and 14 days.
V kliničnih preskušanjih, v katerih je bil indikacija recidiven in odporen NHL so poročali o trombocitopeniji 3. ali 4. stopnje z medianim časom do normalizacije 13 in 21 dni, pri nevtropeniji 3. ali 4. stopnje pa je mediana časa do normalizacije znašala 8 in 14 dni.
Following Zevalin as consolidation after first line remission induction, the median times to recovery were 20 days and 35 days for Grade 3 or 4 thrombocytopenia and 20 days and 28 days for Grade 3 or 4 neutropenia.
Po uporabi zdravila Zevalin kot konsolidacijske terapije za utrjevanje odgovora, ki je bil dosežen s prvim indukcijskim zdravljenjem so bili mediani časi do normalizacije trombocitopenije 3. stopnje 20 dni, trombocitopenije 4. stopnje 35 dni, nevtropenije 3. stopnje 20 dni in nevtropenije 4. stopnje 28 dni.
Infections During the first 13 weeks after treatment with Zevalin, patients very commonly developed infections.
Infekcije V prvih 13 tednih po zdravljenju z Zevalinom so bolniki zelo pogosto zbolevali za infekcijami.
Grade 3 and grade 4 infections were reported commonly.
Običajno so poročali o infekcijah 3. in 4. stopnje.
During follow-up, infections occurred commonly.
Infekcije so se pogosto pojavljale tudi v obdobju kontrolnega spremljanja.
Of these, grade 3 was common, grade 4 uncommon.
Te so bile običajno 3. stopnje, redko pa 4. stopnje.
Secondary malignancies Myelodysplasia/ acute myeloid leukaemia (AML) has been reported in five out of 211 patients assigned to treatment with Zevalin.
Sekundarna maligna obolenja O mielodisplaziji / akutni mieloični levkemiji (AML) so poročali pri 5 od 211 bolnikov, ki so bili zdravljeni z Zevalinom.
The risk of developing secondary myelodysplasia or leukaemia following therapy with alkylating agents is well known.
Tveganje za razvoj sekundarne mielodisplazije ali levkemije po terapiji z alkilirajočimi citostatiki je dobro poznano.
Since all of these patients were pre-treated with alkylating agents, available results provide insufficient data on whether Zevalin contributes to an increased risk of myelodysplasia, or on the extent of risk.
Ker so vsi ti bolniki bili predhodno zdravljeni z alkilirajočimi citostatiki, dobljeni rezultati predstavljajo premalo zanesljiv podatek, na podlagi katerega bi lahko sklepali, ali Zevalin prispeva k povečanemu tveganju za pojav mielodisplazije ali pa to tveganje podaljšuje.
Incidence of adverse reactions by System Organ Class The table below reports adverse reactions by System Organ Class:
Incidenca neželenih učinkov glede na organske sisteme V preglednici spodaj so navedeni neželeni učinki glede na organske sisteme:
In total, infections of any cause occurred very commonly but are listed in the table under the specifically reported term.
Na splošno so se infekcije različnega porekla pojavljale zelo pogosto, vendar so v preglednici označene s posebnim terminom.
(≥ 1/ 1,000 to < 1/ 100)
(≥1/ 1. 000 do < 1/ 100)
(≥ 1/ 10,000 to < 1/ 1,000)
(≥1/ 10. 000 do < 1/ 1. 000)
Infection *, Sepsis *, Pneumonia *,
okužba *, sepsa *, pljučnica *, okužbe sečil, oralna kandidoza
6
6 Organski sistem (MedDRA)
Urinary tract infection, Oral moniliasis,
Bolezni krvi in
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
trombocitopenija,
Tumour pain, Myelodysplastic syndrome / Acute myeloid leukaemia *
febrilna nevtropenija,
Meningioma
limfatičnega
Blood and lymphatic system disorders
levkocitopenija,
Thrombocytopenia, Leukocytopenia, Neutropenia, Anemia *
pancitopenija *,
Febrile neutropenia, Pancytopenia *, Lymphocytopenia
sistema Bolezni imunskega sistema Presnovne in prehranske motnje Psihiatrične motnje Bolezni živčevja Srčne bolezni
Immune system disorders Metabolism and nutrition disorders
nevtropenija, anemija *
Psychiatric disorders Nervous system disorders Cardiac disorders
limfocitopenija preobčutljivostna reakcija anoreksija anksioznost, nespečnost vrtoglavica, glavobol
Anxiety, Insomnia Dizziness, Headache
tahikardija
Tachycardia
Žilne bolezni
Vascular disorders
krvavitev pri
Hemorrhage while thrombocytopenic *
intrakranialne
Intracranial hemorrhage while thrombocyto- penic *
Bolezni dihal, prsnega koša in mediastinalnega prostora
Respiratory, thoracic, and mediastinal disorders
trombocitopeniji * kašelj, rinitis
Gastrointestinal disorders
krvavitve pri trombocitopeniji *
Vomiting, Abdominal pain, Diarrhoea, Dyspepsia, Throat irritation, Constipation
Bolezni prebavil Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
Rash, Pruritus,
slabost
Musculoskeletal, connective tissue and bone disorders
bruhanje, bolečine v trebuhu, driska, dispepsija, draženje grla, zaprtost izpuščaj, pruritus artralgija, mialgija, bolečine v hrbtu, bolečine v vratu
Arthralgia, Myalgia, Back pain, Neck pain
Splošne težave in astenija, pireksija, bolečina, simptomi, spremembe na mestu aplikacije
(≥ 1/ 10)
okorelost
General disorders Asthenia, and administration Pyrexia, site conditions Rigors
podobni gripi, slabotnost, periferni edem, povečano potenje
clinical trials or in post-marketing experience
* V kliničnih preskušanjih ali pri postmarketinškem spremljanju so ugotovili smrtni izid.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Za opis neke reakcije in njenih sinonimov ter povezanih stanj je uporabljen najprimernejši izraz MedDRA.
ADR term representation is based on MedDRA version 9.1.
Poimenovanje neželenih učinkov temelji na MedDRA, verzija 9. 1.
Disease progression is the natural evolution of the underlying disease.
Zaradi svojega naravnega razvoja prikrite bolezni napredujejo.
In the study with 204 patients receiving Zevalin as consolidation following first-line remission induction, infections were observed more frequently than as described in the above table (very common).
V študiji 204 bolnikov, ki so dobivali konsolidacijsko terapijo z zdravilom Zevalin za utrjevanje odgovora, ki je bil dosežen s prvim indukcijskim zdravljenjem, so okužbe opažali pogosteje, kot je opisano v zgornji preglednici (zelo pogosto).
In addition, the following adverse drug reactions were observed in this study:
7 Poleg tega so v tej študiji opazili naslednje neželene učinke zdravila:
• MedDRA SOC General disorders and administration site conditions: fatigue (very common)
• MedDRA SOC – Splošne težave in spremembe na mestu aplikacije: utrujenost (zelo pogosta)
• MedDRA SOC Vascular disorders: petechia (very common), hypertension (common), hypotension (common)
• MedDRA SOC – Žilne bolezni: petehije (zelo pogoste), hipertenzija (pogosta), hipotenzija (pogosta)
• MedDRA SOC Reproductive system and breast disorders: amenorrhoea (common) Post-marketing experience:
• MedDRA SOC – Motnje reprodukcije in dojk: amenoreja (pogosta)
MedDRA SOC Skin and subcutaneous tissue disorders
Postmarketinške izkušnje:
Mucocutaneous reaction, including Stevens Johnson Syndrome with fatal outcome, has been rarely reported in post-marketing experience.
Bolezni kože in podkožja V okviru postmarketinških izkušenj redko poročajo o vplivu na kožo in sluznice, vključno s Stevens - Johnsonovim sindromom, ki se konča s smrtnim izidom.
MedDRA SOC General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije
Isolated reports of extravasation with subsequent infusion site reaction, like dermatitis, desquamation, and site ulcer have been received.
Prejeta so bila posamezna poročila o ekstravazaciji s posledično reakcijo na mestu aplikacije (npr. dermatitis, deskvamacija in razjeda na mestu aplikacije).
Isolated reports have been received showing that Zevalin-associated radiation might cause damage to lymphoma-surrounding tissue and complications due to lymphoma swelling.
Prejeta so bila posamezna poročila, ki kažejo da radiacija zaradi Zevalina lahko povzroči poškodbo tkiva v okolici limfoma in zaplete zaradi otekline limfoma.
Because the Zevalin therapeutic regimen includes the use of rituximab, see also the prescribing information of rituximab.
Ker režim zdravljenja z zdravilom Zevalin vključuje uporabo rituksimaba, glejte tudi informacije o predpisovanju rituksimaba.
Overdose as high as 19.2 MBq/ kg of [90Y]-radiolabelled Zevalin occurred in clinical trials.
Prevelik odmerek, ki so ga zabeležili v kliničnih študijah, je znašal do 19, 2 MBq/ kg z [90Y] označenega Zevalina.
Expected haematological toxicity was observed, comprising Grade 3 or 4.
Opažena hematološka toksičnost 3. ali 4. stopnje je bila pričakovana.
8 There is no known specific antidote for [90Y]-radiolabelled Zevalin overdosage.
Specifično protisredstvo za preveliko odmerjanje z [90Y] označenega Zevalina ni poznano.
Treatment consists of discontinuation of Zevalin and supportive therapy, which may include growth factors.
Zdravljenje temelji na prekinitvi aplikacij Zevalina in podpornem zdravljenju, ki lahko vključuje tudi rastne faktorje.
If available, autologous stem cell support should be administered to manage haematological toxicity.
Če so na razpolago avtologne matične celice, jih je treba uporabiti kot podporo pri obvladovanju hematološke toksičnosti.
For accidental administration of the pure radiopharmaceutical precursor product yttrium-90, refer to the product information of yttrium-90.
Glede nenamerne aplikacije čistega radiofarmacevtskega predhodnika, itrija- 90, glejte povzetek glavnih značilnosti za zdravilo itrij- 90.
Various therapeutic radiopharmaceuticals ATC code:
Razni radioterapevtiki Oznaka ATC:
Ibritumomab tiuxetan is a recombinant murine IgG1 kappa monoclonal antibody specific for the B-cell antigen CD20.
Ibritumomab tiuksetan je kappa monoklonsko protitelo na osnovi rekombinantnega mišjega IgG1, ki je specifično za B- celični antigen CD20.
Ibritumomab tiuxetan targets the antigen CD20 which is located on the surface of malignant and normal B-lymphocytes.
Ibritumomab tiuksetan je usmerjen proti antigenu CD20, ki se nahaja na površini malignih in normalnih limfocitov B.
During B-cell maturation, CD20 is first expressed in the midstage of B-lymphoblast (pre-B-cell), and is lost during the final stage of B-cell maturation to plasma cells.
Med dozorevanjem B celic se CD20 najprej pojavi pri medstopnji B limfoblastov (predstopnja B celic) in se med končnim stadijem dozorevanja B celic v plazemske celice izgubi.
The conjugated antibody has an apparent affinity constant for the CD20 antigen of approximately 17 nM.
Konjugirano protitelo ima očitno afinitetno konstanto za antigen CD20, ki znaša
[90Y]-radiolabelled Zevalin binds specifically to B-cells, including CD20-expressing malignant cells.
Z [90Y] označeni Zevalin se veže specifično na celice B, vključno z malignimi celicami, ki imajo izražen CD20.
The isotope yttrium-90 is a pure β -emitter and has a mean path length of about 5 mm.
Izotop itrij- 90 je čisti sevalec žarkov β z dometom okoli 5 mm.
Rituximab pre-treatment is necessary to clear circulating B-cells, enabling Zevalin to deliver radiation more specifically to the lymphomas.
Predhodno zdravljenje z rituksimabom je potrebno za odstranitev celic B v obtoku, s čimer dosežemo, da je sevanje Zevalina usmerjeno bolj specifično na limfom.
Treatment with [90Y]-radiolabelled Zevalin also leads to depletion of normal CD20+ B-cells.
Zdravljenje z Zevalinom označenim z [90Y] povzroči tudi zmanjšanje števila normalnih CD20 pozitivnih celic B.
Pharmacodynamic analysis demonstrated that this was a temporary effect; recovery of normal B-cells began within 6 months and median counts of B-cells were within normal range within 9 months after treatment.
Farmakodinamična analiza je pokazala, da je ta učinek le začasen; v 6 mesecih so se začele normalne celice B ponovno regenerirati, njihovo mediano število pa je 9 mesecev po zdravljenju bilo znotraj meja normalnih vrednosti.
The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Varnost in učinkovitost zdravljenja z Zevalinom so ocenjevali v dveh multicentričnih študijah, v kateri je bilo vključenih skupno 197 oseb.
The Zevalin therapeutic regimen was administered in two steps (see 4.2).
Terapija z Zevalinom je potekala v dveh fazah (glejte poglaveje 4. 2).
The efficacy and toxicity of a variation of the Zevalin therapeutic regimen employing a reduced activity of [90Y]-Zevalin was further defined in a third study enrolling a total of 30 patients who had mild thrombocytopenia (platelet count 100,000 to 149,000 cells/ mm3).
Učinkovitost in toksičnost različice terapevtske sheme z Zevalinom, pri kateri so uporabljali nižje aktivnosti z [90Y] označenega Zevalina, so nadalje proučevali v tretji študiji, v katero je bilo vključenih skupno 30 bolnikov z blago trombocitopenijo (število trombocitov med 100. 000 - 149. 000 celic/ mm3).
Study 1 was a single arm study of 54 patients with relapsed follicular lymphoma refractory to rituximab treatment.
Prva študija je imela en krak, v katerem je bilo 54 bolnikov s ponovitvijo folikularnega limfoma, brez odgovora na zdravljenje z rituksimabom.
Patients were considered refractory if their last prior treatment with rituximab did not result in a complete or partial response, or if time to disease progression (TTP) was < 6 months.
Bolniki brez odgovora so bili tisti, pri katerih po zadnjem predhodnem zdravljenju z rituksimabom ni prišlo do popolne ali delne remisije, oziroma, če je bil čas do napredovanja bolezni (TPP – time to progress) < 6 mesecev.