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Tilbake til: Farma og medisin
Innlegg av: Frontmasta (13.12.17 23:25 ), lest 4632 ganger
Ticker: NANO
Endret: 14.12.17 00:19

NANO. Dose and efficacy study - 80 centres worldwide

Study of Betalutin® for relapsed follicular lymphoma

Part 2 additional 80 patients..


https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/dose-and-efficacy-study-of-betalutin-for-relapsed-follicular-lymphoma/

Tenker at dette er endring av Lymrit 37-06.

EudraCT Number: 2015-001570-17

Sjekk opp folkens, Costa forteller bare det han må........

Innlegg av: Bullinvestor (13.12.17 23:41 ), lest 3222 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Du mener han sparer det beste til slutt ?:)
Innlegg av: Frontmasta (13.12.17 23:55 ), lest 3145 ganger
Ticker: NANO
Endret: 14.12.17 00:21

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Costa og ledelsen er nok samstemte om hvordan man kan skjule hva de vet. Hva de holder på med skjules også i forskjellige databaser for det er nå en gang slik når man holder på med nye preparater.

Dette er nok bevist fra ledelsen. At de ikke oppdaterer databasene er bare et av disse momentene.

Her er samme studien, men i en annen utgave....... med HU til slutt.

http://apps.who.int/trialsearch/Trial3.aspx?trialid=EUCTR2015-001570-17-HU
Innlegg av: Ramleren (14.12.17 00:03 ), lest 3088 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Utdrag fra linken til Frontmasta.Det er Archer studien og det velges Rituximab (Roche)som predosering.

Research summary
Follicular lymphoma is a type of slow-growing blood cancer involving B-lymphocytes that can be treated effectively with chemotherapy and immunotherapy, however, relapses often occur and therefore there is a need for new types of treatment. In many cases radioimmunotherapy is effective. It uses antibodies with a radioisotope attached to deliver a dose of radiation to the cancer cells to destroy them. The purpose of this study is to test Betalutin, a new type of radioimmunotherapy, in which the radioisotope Lutetium-177 is attached to the antibody HH1. Betalutin binds to both cancerous and normal B-lymphocytes. The numbers of both are expected to fall following the treatment. This may increase the risk of infections but the number of B-lymphocytes is expected to recover within 12 months. Rituximab, an established immunotherapy, is used as a pre-treatment in the study to clear circulating normal B-lymphocytes to give Betalutin a better chance to bind to hard-to-reach cancerous cells.
The study will enrol adult patients with follicular lymphoma who have relapsed following at least 2 prior systemic treatments. This open-label study consists of two parts. Part 1 is designed to establish the optimal Betalutin treatment regimen in terms of effectiveness and safety. 45 patients will be equally randomised into 3 treatment arms. In Part 2, an additional 80 patients will receive the optimal treatment regimen established in part 1 to assess its effectiveness. The patients will undergo screening procedures to confirm if they can take part. Eligible patients will be pre-treated with 2 doses of Rituximab, and dependant on which arm they are randomised to, an infusion of HH1 followed by a single dose of Betalutin. After the Betalutin injection the patients will be followed up weekly for 12 weeks, then every 3 months until month 12, then every 6 months for a further 4 years. Assessments for this study include physical examinations, ECG, blood and urine samples, CT/PET scans, tumour and bone marrow biopsy. The study will be run at approximately 80 centres worldwide.
Innlegg av: TyrionIV (14.12.17 07:58 ), lest 1249 ganger
Ticker: NANO

RE^2: NANO. Dose and efficacy study - 80 centres worldwide

Det er Paradigme-studien..

"who have relapsed following at least 2 prior systemic treatments"

I Archer-studien er det for øvrig planen å ha rituximab i flere små doser ETTER Betalutin..
Innlegg av: Bullinvestor (14.12.17 00:04 ), lest 3078 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Ja Frontmasta det er nok her focuss og mange andre er blitt lurt.. meget viktig å kunne lese mellom linjene!!
Tror mye positivt kursmessig kan skje før Julen ringer inn:-)
Innlegg av: FreeHeal (14.12.17 00:23 ), lest 2494 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

2015.....
Innlegg av: Frontmasta (14.12.17 00:30 ), lest 2465 ganger
Ticker: NANO
Endret: 14.12.17 00:32

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

JEPP.......2015 Tog du ann.........
Innlegg av: fabian2 (14.12.17 00:47 ), lest 2113 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Tusen takk for spennende info ! "Superhappy"
Innlegg av: TeeJay (14.12.17 06:10 ), lest 1606 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Fase 1: Doseoptimalisering:
45 pasienter i 3 randomiserte armer:
15/40, 20/60, 20/100 - 15 i hver ?
Innlegg av: Londonmannen (14.12.17 07:05 ), lest 1480 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Dokumentet er datert SEP 2015. Teoretisk kunne studie ha sluttdato 31des 2021.i så tilfelle skulle fase 1 vært ferdig i desember 2016. Det vet vi ikke stemmer. Men dersom fase 2 starter med Archer-1, så skal studien avsluttes 31 DES 2022.

Frontmasta
Cred for din grevlingsvirksomhet. Keep up the digging!
Innlegg av: Sydney (14.12.17 13:05 ), lest 830 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Masta! Du som graver en del, eller noen andre: hvor mange land må nano søke oppstart paradigme i? Er det kun europa og usa eller er det flere? Som for eks eu, usa og norge pluss alle landene aom skal være inkludert? Nano sa til einaraon at paradigme stusiet var godkjent i ett land, og at de derfor har satt i gang, dette kan jo fort være norge.
Innlegg av: FreeHeal (14.12.17 13:17 ), lest 768 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

FDA foretrekker at minst 10% er gjort i USA ?!?!?!?

USA og EU er pri en marked, sekundert "alle" andre marked/land.
Innlegg av: Frontmasta (14.12.17 16:46 ), lest 666 ganger
Ticker: NANO
Endret: 14.12.17 16:50

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Publisert 15 mars 2017

http://app.hemotrial.es/inicio/ensayo-clinico?cid[0]=9175&task2=edit&tmpl=component&print=1

Publisert for 6 dager siden - 9 hospital i Spania

https://nomenclator.org/estudio-para-identificarl-la-dosis-mas-efectiva-de-betalutin-en-pacientes-con-un.ec

37 - 06 pågår men ikke oppdatert siden begynnelsen på 2016 i REK

https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=610673&p_parent_id=617305&_ikbLanguageCode=n

Studier i Spania som ikke er publisert på hjemmesiden ?

What...................Costa?


Innlegg av: Londonmannen (14.12.17 17:13 ), lest 553 ganger
Ticker: NANO

RE^1: NANO. Dose and efficacy study - 80 centres worldwide

Skjer en del i kulissene.....