natgillin/translations-raw huggingface dataset:
De mest almindelige forudgående hudrettede behandlinger i ITT-populationen var strålebehandling (64 %), lysbehandling (48 %) og topikale steroider (17 %). 
The most common prior skin directed therapies in the ITT population were radiotherapy (64%), phototherapy (48%) and topical steroids (17%).
Brugen af ADCETRIS i kombination med kemoterapi bør undgås hos patienter med moderat og svært nedsat leverfunktion. 
Use of ADCETRIS in combination with chemotherapy should be avoided in patients with moderate and severe hepatic impairment.
Blandt de patienter i de pivotale fase 2-studier (SG035-0003 og SG035-0004) samt randomiserede fase 3-studier med monoterapi (SGN35-005 og C25001), der oplevede perifer neuropati, lå den mediane opfølgningstid fra afslutning af behandlingen til sidste evaluering i intervallet 48,9 til 98 uger. 
Among patients who experienced peripheral neuropathy in the pivotal phase 2 studies (SG035-0003 and SG035-0004) and randomised phase 3 monotherapy studies (SGN35-005 and C25001), the median follow up time from end of treatment until last evaluation ranged from 48.9 to 98 weeks.
Lægen eller sundhedspersonalet vil bortskaffe medicinenrester. 
The doctor or nurse will dispose of this medicine.
Derfor er samtidig administration af ADCETRIS og bleomycin kontraindiceret (se pkt. 
Therefore, co-administration of ADCETRIS with bleomycin is contraindicated (see section 4.2).
For de patienter, som tidligere havde fået 1 cancerrelateret behandling, blev CR rapporteret for 1 patient (9 %), og PR blev rapporteret for 4 patienter (36 %). 
For the patients who received 1 prior cancer-related treatment, CR was reported for 1 patient (9%) and PR was reported for 4 patients (36%).
Brentuximab vedotin er et antistof-lægemiddel-konjugat (ADC), som frigiver et antineoplastisk middel, der medfører apoptotisk celledød selektivt i tumorceller, der udtrykker CD30. 
Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells.
Disse patienter bør have op til 16 behandlingsserier (se pkt. 
These patients should receive up to 16 cycles (see section 5.1).
Brugen af ADCETRIS i kombination med kemoterapi bør undgås hos patienter med svært nedsat nyrefunktion. 
Use of ADCETRIS in combination with chemotherapy should be avoided in patients with severe renal impairment.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AFIKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF 
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Kombinationsbehandling Bemærk: Primær profylakse med G-CSF anbefales til alle patienter, der får kombinationsbehandling, startende med den første dosis 
Combination therapy Note: Primary prophylaxis with G-CSF is recommended for all patients receiving combination therapy beginning with the first dose.
Se nedenstående Tabel 1 for passende doseringsanbefalinger (se også pkt. 
See Table 1 below for appropriate dosing recommendations (see also section 4.4).
Bivirkninger førte til seponering af behandlingen hos 13 % af patienterne. 
Adverse events led to treatment discontinuation in 13% of patients.
Analyserne viste en ensartet tendens mod en fordel for patienter, der fik ADCETRIS, sammenlignet med patienter, der fik lægens valg. 
The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received physician's choice.
Kvalme, obstipation, opkastning, diarré, abdominalsmerter, stomatit 
Nausea, constipation, vomiting, diarrhoea, abdominal pain, stomatitis
- Stevens-Johnsons syndrom - en sjælden, alvorlig sygdom, hvor du kan opleve influenzalignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der spreder sig og danner blærer, herunder omfattende afskalning af huden - nye eller tilbagevendende cytomegalovirusinfektioner (CMV) 
- Stevens-Johnson syndrome - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - new or recurring cytomegalovirus (CMV) infection
ADCETRIS-dosis (mg/kg) x patientens vægt (kg) = Total ADCETRIS-dosis (mL) der skal yderligere fortyndes 
ADCETRIS dose (mg/kg) x patient's body weight (kg)
Efter flere doser ved intravenøs infusion af 1,2 mg/kg brentuximab vedotin hver anden uge blev der observeret maksimale serumkoncentrationer ved slutningen af infusionen, og elimination udviste et multieksponentielt fald med en t1/2z på cirka 4 til 5 dage. 
After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, maximal serum concentrations of ADC were observed near the end of the infusion and elimination exhibited a multi-exponential decline with a t1/2z of approximately 4 to 5 days.
Hvis der udvikles Grad 3 eller Grad 4 neutropeni, se pkt. 
If Grade 3 or Grade 4 neutropenia develops, refer to section 4.2.
En eksplorativ intra-patient-analyse viste, at omkring 64 % af HL-patienterne behandlet med ADCETRIS som en del af det kliniske studie SG035-003 oplevede en forbedring i klinisk gavn målt ved længere progressionsfri overlevelse (PFS) sammenlignet med deres seneste tidligere behandling. 
An exploratory intra-patient analysis showed that approximately 64% of the HL patients treated with ADCETRIS as part of the SG035-0003 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
På tidspunktet for den sidste evaluering havde de fleste af patienterne (76 %), der oplevede perifer neuropati, ophør eller bedring af deres symptomer på perifer neuropati. 
At the time of last evaluation, most of the patients (76%) who experienced peripheral neuropathy had resolution or improvement of their peripheral neuropathy symptoms.
Patient-katakteristika n = 58 
Patient characteristics n = 58
Den anbefalede dosis i kombination med kemoterapi (doxorubicin [A], vinblastin [V] og dacarbazin [D] [AVD]) er 1,2 mg/mg administreret som en intravenøs infusion over 30 minutter på dag 1 og 15 i hver 28-dages behandlingsserie i 6 serier (se pkt. 
The recommended dose in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see section 5.1).
Anafylaktiske reaktioner er rapporteret (se pkt. 
Anaphylactic reactions have been reported (see section 4.4).
Primært refraktær sALCLdefineres som manglende opnåelse af komplet remission efter primær behandling eller progression inden for 3 måneder efter afslutning af denne. 
Primary refractory HL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Sammenlignet med patienter med normal leverfunktion er MMAE-eksponeringen øget cirka 2,3 gange (90 % CI 1,27-4,12 gange) hos patienter med nedsat leverfunktion. 
Compared to patients with normal hepatic function, MMAE exposure increased approximately 2.3-fold (90% CI 1.27-4.12-fold) in patients with hepatic impairment.
Den sædvanlige dosis af Adcetris givet i kombination med anden kemoterapi er 1,2 mg/kg givet hver 2. uge i 6 måneder. 
The usual dose of Adcetris given in combination with other chemotherapy medicines is 1.2 mg/kg given every 2 weeks for 6 months.
Primær refraktær på førstelinjebehandling Refraktært på den seneste behandling Recidiveretpå den seneste behandling Baseline B-symptomer Stadium III ved initiel diagnose Stadium IV ved initiel diagnose a. 
Primary Refractory to frontline therapy Refractory to most recent therapy Relapsed to most recent therapy Baseline B symptoms Stage III at initial diagnosis Stage IV at initial diagnosis a.
Den mediane varighed af behandling for patienter, som seponerede behandlingen på grund af perifer neuropati, var 12 behandlingsserier. 
The median duration of treatment for patients who discontinued due to peripheral neuropathy was 12 cycles.
Tabel 16: Beregninger for patienter, der får den anbefalede dosis på 1,2 mg/kg ADCETRIS for et vægtinterval mellem 60 kg og 120 kg som kombinationsbehandling, eller når der kræves reduceret dosis 
Table 16: Sample calculations for patients receiving the recommended dose of 1.2 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg as combination therapy or when a reduced dose is required
Der var en tendens til øget clearance af brentuximab vedotin hos pædiatriske patienter med bekræftet positiv ADA. 
There was a trend of increased clearance of brentuximab vedotin in paediatric patients confirmed positive for ADAs.
Perifer neuropati medførte seponering af behandlingen hos 15 %, dosisreduktioner hos 15 % og udsat dosering hos 17 % af patienterne. 
Peripheral neuropathy led to treatment discontinuation in 15%, dose reductions in 15%, and dose delays in 17% of patients.
Tilsæt ikke andre lægemidler til den klargjorte Adcetris-infusionsopløsning eller det intravenøse infusionssæt. 
Do not add other medicinal products to the prepared ADCETRIS infusion solution or intravenous infusion set.
Grad 3 neutropeni blev rapporteret hos 13 % af patienterne, og Grad 4 neutropeni blev rapporteret hos 5 % af patienterne. 
Grade 3 neutropenia was reported in 13% and Grade 4 neutropenia was reported in 5% of patients.
De 32 patienter (53 %), som ikke efterfølgende fik ASCT, fik også ADCETRIS i et mediant antal serier på 7 (interval 1 til 16 serier). 
The 32 patients (53%) who did not receive subsequent SCT also received ADCETRIS for a median of 7 cycles (range, 1 to 16 cycles).
De farmakokinetiske karakteristika for henholdsvis ADC og MMAE i serum og plasma efter administration af brentuximab vedotin i kombination med AVD svarede til monoterapi. 
The serum and plasma pharmacokinetic characteristics of ADC and MMAE respectively following administration of brentuximab vedotin in combination with AVD were similar to that in monotherapy.
Seponer behandlingen 
Discontinue treatment
Sammenlignet med patienter med normal nyrefunktion er MMAE-eksponeringen øget cirka 1,9 gange (90 % CI 0,85-4,21 gange) hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min). 
Compared to patients with normal renal function, MMAE exposure increased approximately 1.9-fold (90% CI 0.85-4.21-fold) in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Et multieksponentielt fald i serumkoncentrationer af ADC blev observeret med en terminal halveringstid på cirka 4 til 5 dage. 
A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 5 days.
Grad 4 (<500/mm <0,5 x 10 
Grade 4 (< 500/mm < 0.5 x 10
Fuldblodstal skal monitoreres før administration af hver enkelt behandlingsdosis. 
Complete blood counts should be monitored prior to administration of each dose of treatment.
p-værdi = 0,035 
p-value=0.035
Infusionsrelaterede reaktioner 
Infusion-related reactions
Tumorlyse-syndrom (TLS) er rapporteret ved ADCETRIS. 
Tumour lysis syndrome (TLS) has been reported with ADCETRIS.
Efter flere doser ved intravenøs infusion af 1,2 mg/kg brentuximab vedotin hver anden uge blev steady state-dalkoncentrationerne for ADC og MMAE opnået ved behandlingsserie 3. 
After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, steady-state trough concentrations of ADC and MMAE were achieved by Cycle 3.
Forhøjet alaninaminotransferase/ aspartataminotransferase (ALAT/ASAT) 
Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Aktivt stof: Brentuximab vedotin. 
- The active substance is brentuximab vedotin.
Samtidig administration af midazolam, et CYP3A4-substrat, og brentuximab vedotin ændrede ikke metabolismen af midazolam; derfor forventes brentuximab vedotin ikke at ændre eksponeringen for lægemidler, der metaboliseres af CYP3A4-enzymer. 
Co-administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes.
IRF blev udført efter patienternes bedste respons på salvage-behandling før ASCT, HL-status efter primær behandling, alder, køn, vægt ved baseline, ECOG-performancestatus ved baseline, antal behandlinger før ASCT, geografisk område, PET-status før ASCT, B-symptomstatus efter svigt af primær behandling samt status for ekstranodal sygdom før ASCT. 
Pre-specified subgroup analyses of PFS per IRF were performed by patients' best response to pre-ASCT salvage therapy, HL status after frontline therapy, age, gender, baseline weight, baseline ECOG performance status, number of treatments pre-ASCT, geographic region, pre-ASCT PET status, B symptom status after failure of frontline therapy, and pre-ASCT extranodal disease status.
Vend forsigtigt posen for at blande den opløsning, der indeholder ADCETRIS. 
Gently invert the bag to mix the solution containing Adcetris.
Perifer neuropati medførte seponering af behandlingen hos 7 %, dosisreduktioner hos 21 % og udsat dosering hos 1 % af patienterne. 
Peripheral neuropathy led to treatment discontinuation in 7%, dose reductions in 21%, and dose delays in 1% of patients.
Den sædvanlige dosis af Adcetris alene er 1,8 mg/kg givet en gang hver 3. uge i højst et år. 
The usual dose of Adcetris given alone is 1.8 mg/kg, given once every 3 weeks for no more than one year.
Hvis SJS eller TEN forekommer, skal ADCETRIS seponeres, og passende behandling iværksættes. 
If SJS or TEN occur, ADCETRIS should be discontinued and appropriate medical therapy should be administered.
Atten (18) patienter (18 %) modtog 16 behandlingsserier ADCETRIS; og det mediane antal modtagne behandlingsserier var 9 (interval fra 1 til 16). 
Eighteen (18) patients (18%) received 16 cycles of ADCETRIS; and the median number of cycles received was 9 (ranging from 1 to 16).
Ikkestratificeret Hazard Ratio og p-værdi 
Unstratified Hazard Ratio and p-value
Virkningen i den ældre patientpopulation (patienter ≥ 60 år [n = 186] [HR = 1,00; 95 % CI (0,58; 1,72)] og ≥ 65 år [n = 122] [HR = 1,01; 95 % CI (0,53; 1,94)]) samt patienter uden ekstranodale steder (n = 445) (HR = 1,04; 95 % CI [0,67; 1,62]) viste ingen klinisk betydningsfuld forskel mellem de to arme. 
The efficacy in elderly patient population (patients ≥ 60 years of age [n = 186] [HR = 1.00, 95% CI (0.58, 1.72)] and ≥ 65 years of age [n = 122] [HR = 1.01, 95% CI (0.53, 1.94)]) and patients with no extranodal sites (n = 445) (HR = 1.04, 95% CI [0.67, 1.62]) showed no clinically meaningful difference between the two arms.
IRF-vurdering var 75 % (76 af 102 patienter i ‘intent-to-treat' [ITT]-gruppen), og tumorreduktion blev opnået hos 94 % af patienterne. 
The objective response rate (ORR) per IRF assessment was 75% (76 of 102 patients in the intent-to-treat [ITT] set) and tumour reduction was achieved in 94% of patients.
Af de 1.334 patienter blev 664 patienter randomiseret til ADCETRIS + AVD-armen, og 670 patienter blev randomiseret til ABVD-armen (doxorubicin [A], bleomycin [B], vinblastin [V] og dacarbazin [D]) og inddelt efter antallet af IPFP-risikofaktorer (International Prognostic Factor Project) og område. 
Sixty-two percent of patients had extranodal site involvement Of the 1334 patients, 664 patients were randomised to the ADCETRIS + AVD arm and 670 patients were randomised to the ABVD (doxorubicin [A], bleomycin [B], vinblastine [V] and dacarbazine [D]) arm and stratified by number of International Prognostic Factor Project (IPFP) risk factors and region.
Opbevares i den originale ydrepakning for at beskytte mod lys. 
Keep the vial in the original carton in order to protect from light.
Mediantid fra HL-diagnose til første dosis (interval) 0,92 mdr. 
Median time from HL diagnosis to first dose (range) 0.92 mo (0.1-21.4)
IRF og OS efter antal risikofaktorer i HL post-ASCT fase 3studiet 
Table 8: Summary of PFS per IRF and OS by number of risk factors in the phase 3 HL post-ASCT Study
• Ekstranodal sygdom ved recidiv før ASCT 
• Extranodal disease at pre-ASCT relapse
ADCETRIS 50 mg pulver til koncentrat til infusionsvæske, opløsning. 
ADCETRIS 50 mg powder for concentrate for solution for infusion.
Adcetris er kun til engangsbrug. 
ADCETRIS is for single use only.
I ITT-populationen fik 33 % færre patienter, der fik behandling med ADCETRIS + AVD, efterfølgende salvage-kemoterapi (n = 66) samt højdosis-kemoterapi og transplantation (n = 36) sammenlignet med de patienter, der fik behandling med ABVD (henholdsvis n = 99 og n = 54). 
In the ITT population, 33% fewer patients treated with ADCETRIS + AVD in the ITT population received subsequent salvage chemotherapy (n = 66) and high-dose chemotherapy and transplant (n = 36) compared with those treated with ABVD (n = 99 and n = 54, respectively).
ADCETRIS er indiceret til behandling af voksne patienter med ikke tidligere behandlet CD30+ Hodgkins lymfom (HL) stadie IV i kombination med doxorubicin, vinblastin og dacarbazin (AVD) (se pkt. 
ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD)(see sections 4.2 and 5.1).
Tilfælde af lungetoksictet, herunder pneumoni, interstitiel lungesygdom og Acute Respiratory Distress Syndrome (ARDS; akut lungesvigt), nogle med dødelig udgang, er rapporteret hos patienter i behandling med ADCETRIS. 
Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS.
Administration af brentuximab vedotin samtidigt med ketoconazol, en stærk CYP3A4 og P-gphæmmer, øgede eksponeringen for antimikrotubulus-midlet MMAE med cirka 73 % og ændrede ikke plasmaeksponeringen for brentuximab vedotin. 
Co-administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P-gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin.
Tilbagehold dosis, indtil toksiciteten vender tilbage til ≤ Grad 2 eller baseline, genoptag derefter behandlingen med samme dosis og plan b. Overvej 
Withhold dose until toxicity returns to ≤ Grade 2 or baseline then resume treatment at the same dose and schedule .
Patienter med stadie IV-sygdom, for hvem der blev rapporteret ekstranodal sygdom ([n = 722] [HR = 0,69; 95 % CI (0,50, 0,94)]), havde en fordel, hvad angår mPFS (per IRF). 
Patients with Stage IV disease for whom extranodal disease was reported ([n = 722] [HR = 0.69, 95% CI (0.50, 0.94)]) showed an mPFS (per IRF) benefit.
Slyng forsigtigt hætteglasset for at hjælpe med opløsningen. 
Gently swirl the vial to aid dissolution.
Det allerede rekonstituerede ADCETRIS kan også fortyndes i 5 % dextrose til injektion eller Ringerlaktat til injektion. 
The already reconstituted ADCETRIS can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Det allerede rekonstituerede Adcetris kan også fortyndes i 5% dextrose til injektion eller Ringerlaktat til injektion. 
The already reconstituted Adcetris can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
En præspecificeret subgruppeanalyse af mPFS efter sygdomsstadie viste, at patienter med stadie IV-sygdom oplevede en større effekt sammenlignet med ITT-populationen, med en ikke-stratificeret hazard ratio på 0,71 (95 % CI, 0,53; 0,96), sammenlignelig med en 29 % reduktion i risikoen for modificerede PFS-hændelser for ADCETRIS + AVD kontra ABVD. 
A pre-specified subgroup analysis of mPFS by disease stage showed that patients with Stage IV disease had a larger effect compared with the ITT population, with an unstratified hazard ratio of 0.71 (95% CI, 0.53; 0.96), compatible with a 29% reduction in the risk of modified PFS events for ADCETRIS+ AVD versus ABVD.
I studiet af ADCETRIS som kombinationsbehandling med AVD hos 662 patienter med ikke tidligere behandlet fremskreden HL (C25003) var de mest almindelige bivirkninger (≥ 10 %): neutropeni, kvalme, obstipation, opkastning, træthed, perifer sensorisk neuropati, diarré, pyreksi, alopeci, perifer motorisk neuropati, vægttab, abdominalsmerter, anæmi, stomatit, febril neutropeni, knoglesmerter, insomni, appetitmangel, hoste, hovedpine, artralgi, rygsmerter, dyspnø, myalgi, infektion i de øvre luftveje og forhøjet alaninaminotransferase. 
In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced HL (C25003), the most common adverse reactions (≥ 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased.
Objektiv responsrate (CR + PR) Komplet remission (CR) Partiel remission (PR) 
Objective response rate (CR + PR) Complete remission (CR) Partial remission (PR)
Brentuximab vedotin medførte embryo-føtal letalitet hos drægtige hunrotter. 
Brentuximab vedotin caused embryo-foetal lethality in pregnant female rats.
378 M (57) 286 K (43) 
378M (57) 286F (43)
Området for DOR var 1,2+ måneder til 43+ måneder, og den mediane opfølgningstid fra første dosis for patienter, der opnåede objektiv respons (OR) iht. 
The range of DOR was 1.2+ months to 43+ months and the median follow-up time from first dose for patients who achieved objective response (OR) per IRF was 9.0 months.
Hæmatologiske toksiciteter 
Haematological toxicities
Perifer sensorisk neuropati, perifer motorisk neuropati 
Peripheral sensory neuropathy, peripheral motor neuropathy
58,5 år (22-83) 
58.5 years (22-83)
Fuldblodstal skal monitoreres før administration af hver enkelt dosis af denne behandling (se pkt. 
Complete blood counts should be monitored prior to administration of each dose of this treatment (see section 4.4).
Se produktresuméet for de kemoterapeutika, der gives i kombination med ADCETRIS, ved behandling af patienter med ikke tidligere behandlet HL. 
Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL.
Hud og subkutane væv Meget almindelig: 
Skin and subcutaneous tissue disorders Very common:
Et multieksponentielt fald i ADC-serumkoncentrationer blev observeret ved en terminal halveringstid på cirka 4 til 6 dage. 
A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 6 days.
ADCETRIS' virkning og sikkerhed som enkeltstof blev evalueret i et åbent, randomiseret, pivotalt fase 3-multicenterstudie med 128 patienter med histologisk bekræftet CD30+ CTCL. 
The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal phase 3, openlabel, randomised, multicentre study in 128 patients with histologically confirmed CD30+ CTCL.
Der skal gennemføres et enkelt-armet studie med en population tilsvarende sALCL-populationen, som skal kortlægge responsraten, varigheden af respons, tiden ind til anden ASCT samt data for underliggende populationer (inkluderende men ikke nødvendigvis forbeholdt ALK status og alder). 
To perform a single-arm study in a similar patient population as the sALCL population investigating response rate, duration of response, rate of (second) ASCT and data in subpopulations (including but not necessarily restricted to ALK status and age) based on a CHMP agreed protocol (Study C25006).