MO40597 - Obinutuzumab Short Duration Infusion

• Research type

  Research Study

• Full title

  A MULTICENTRIC, OPEN-LABEL, SINGLE ARM STUDY OF OBINUTUZUMAB SHORT DURATION INFUSION (SDI) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED FOLLICULAR LYMPHOMA

• IRAS ID

  256644

• Contact name

  Head of Regulatory Management

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2018-003255-38

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Research Summary:

  Non-Hodgkin lymphoma(NHL)is the most common hematologic malignancy in adults.In 2018, there were estimated to be 74,680 new cases and 19,910 deaths due to NHL in the United States and 97,400 new cases and 39,500 deaths in Europe.\nFollicular lymphoma, a histological sub-type of NHL,remains an incurable disease with the currently available therapies.Despite significant therapeutic progress with the use of chemoimmunotherapy as first-line treatment, most patients eventually experience disease relapse.Thus,new treatments are needed to improve the outcome for these patients.One such candidate is obinutuzumab,a novel glyco-engineered anti-CD20 monoclonal antibody that has shown efficacy with an acceptable toxicity profile in clinical trials.Obinutuzumab has been granted approval for use in patients with previously untreated FL in the EU, US and elsewhere.UK patients routinely receive obinutuzumab as per NICE guidelines.\nThe administration of obinutuzumab is associated with Infusion Related Reactions (IRRs).The incidence of IRRs is greatest with the first infusion and decreases significantly with subsequent infusions.To reduce the risk of IRRs,the first dose is administered at a low rate initially and gradually increased every 30 minutes.If no IRR occurs during the first infusion,subsequent infusions can be given over shorter times however a typical infusion of obinutuzumab can take around 4 hours.\nShorter infusion times would yield substantial time savings for patients and benefit outpatient infusion facilities.The aim of this study is to evaluate whether a short duration infusion(SDI;target 90 minute infusion) can be used for obinutuzumab induction therapy during cycle 2 and from cycle 2 onwards(including obinutuzumab maintenance therapy)in combination with chemotherapy in patients with previously untreated advanced FL.\n112 patients will be recruited globally into this single arm study with 12 patients at 3 sites in the UK.The study will last approximately 4 years from first patient screened to last patient last visit.\nThe study is sponsored by F.Hoffman La Roche.\nResearch Summary; Version 1.0(06/03/2019).

  Summary of Results:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdpiW8szdqMIQBJhHOi3kDeXZVGrOk5i8Z6i9FrLdT5AkhvMPc5-2BKJ9mhE-2FSw6TCCDU552yWq26ZUav8xSUX2MI6xjnP-2FigVh-2B3zRdAZrlByJg3u-2FdVPughvSmq-2BgeXzsfjkHye_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJGxT0vj1anqUhWbwVR7GSA87rtCFXzaHP-2BOrLbTefLs-2BcUJhbvHmL3HGof7LDtmWZRSG21yAHwhB2jrQVOae-2B9KfIWZm8ZQb9JUxcx-2FZoOfwc3FZWOJIQawsMI-2Fw-2BTbQO8CqGvNfdsjFa8xg-2BXISe1VLDp3fVNOnVD0BxqEG1sQQ-3D-3D&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7C0b2cb34f77d5495db4ae08dc11186779%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638404043709482272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=ZpE3TS3ewXWIqhHfsMyis%2FyKmYNFSjnMBCQPQVh9cG0%3D&reserved=0

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  19/YH/0117

• Date of REC Opinion

  13 May 2019

• REC opinion

  Further Information Favourable Opinion