EVALUATING OBINUTUZUMAB, POLATUZUMAB VEDOTIN & LENALIDOMIDE THERAPY

• Research type

  Research Study

• Full title

  A PHASE Ib/II STUDY EVALUATING THE SAFETY AND EFFICACY OF OBINUTUZUMAB IN COMBINATION WITH POLATUZUMAB VEDOTIN AND LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA AND RITUXIMAB IN COMBINATION WITH POLATUZUMAB VEDOTIN AND LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA.

• IRAS ID

  194133

• Contact name

  Head EU/RoW Pharmaceuticals Division, PDR

• Contact email

  welwyn.eudract@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd.

• Eudract number

  2015-001999-22

• Duration of Study in the UK

  5 years, 7 months, 30 days

• Research summary

  Research Summary

  Non-Hodgkin Lymphoma (NHL) is the most common lymphoma in adults. There are a variety of lymphoma subtypes, which are broadly divided into slow growing and aggressive lymphomas, each with unique characteristics. Follicular Lymphoma (FL) is the most common subtype of the slow growing lymphomas and Diffuse Large B-Cell Lymphoma (DLBCL) the most common aggressive NHL. Though there has been significant therapeutic progress by combining antibody and chemotherapy (chemoimmunotherapy) most patients will FL eventually relapse after this treatment and nearly 40% of patients with DLBCL will eventually die of relapsed disease or have disease resistant to this current treatment.

  This study aims to evaluate the activity of a new combination of 3 drugs, Obinutuzumab (a synthetic antibody which helps the immune system attack cancer cells), Polatuzumab Veditin (an antibody combined with an anti-cancer drug which targets and kills specific cancer cells) and Lenalidomide (affects how the immune system works and cell processes, including how cells divide and grow). Currently, data available from a few other studies and laboratory data suggest there is a strong justification that this drug combination will be better than the current treatment available.

  This study will evaluate the triplet drug combination in two phases. The first, drug escalation stage will evaluate different dose levels of the drugs to find out what effects the study treatment has in order to determine the most effective and safe dose. Only patients with FL will take part in this stage. In the second, drug expansion stage patients with FL and DLBCL will take the drug combination at the dose found to be most effective and safe in the first phase to further study the safety and effects of the triplet drug combination.

  Summary of Results

  ● https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzlWmdLsfa60LRnSZate0ioCRDuiiIAHnetis8k-2B-2BwpUQ-3D24Eb_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK-2FFKzf1ZSPCjt8CQJYqu-2BeBm-2FBUVX2NtWk0e3WKUP-2FwcQN9MdOtOn0QKeK8tbKrwU16I3YpqkS3Wet8UwJs1gU21MkXgEi20s-2B14dskGyL1mtjMiLLGuu4IWkdI7BjkamkJP4PZsww9iSw1ovWr0tW8DwGbr-2BvwCr2Hq9AsTaZog-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C37be7db22d15435a50f608dadf4d9ac1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638067821643181248%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=K0%2F7KCGK2kO0xynFP2HljNKdgKHxWc10z373BTXpEFs%3D&reserved=0
  ● https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImualqfjI4EWGRCq5YsNji0bHvTXrk3O1-2FCSmetXqCxRtPto-3Dwq4P_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK-2FFKzf1ZSPCjt8CQJYqu-2BeMt5Y3LX89nHiofpC9XYLRk1OjJA3WG-2Fxk1olal6idvJ7kfOBspiPN7fuFmRn4rbAcbNN9cCGxCJ9E9L5Ts-2FzmrhNzk31-2FtND99wx7gcl-2BZGVFjYPztGOuR12asRveTYmR0vSpQq4CylM1bkucPa8nQ-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C37be7db22d15435a50f608dadf4d9ac1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638067821643181248%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=KzT1YAaV%2FyHhwMHNG19JvlUeYHyTqQoydKq3I4VTCNc%3D&reserved=0
  ● https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdpiW8szdqMIQBJhHOi3kDeXeHBDivoHzOV2QpW-2F53BUcXS5nDV8-2BSWjsYryYT4sZ3ggxD1i4-2FR28b3J-2FV7mVqotdOfEH8rODE3Rzdi0YPjnUDzZd9EWPRL-2FIZMV8HnKtGiMkA-2BoItzNQuqgmWuttF4pw-3D-3D68Kx_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK-2FFKzf1ZSPCjt8CQJYqu-2Bee3gBaag84Z6bJA-2BNIwlHaLFwhQpSBsKVWXTmKDeIdDgxIIA8XXniKGBPLttp0mvbnGNuUio8QyuF1aT-2BOYwf-2FuaoSt5IrBaJN7F0HD2YHlutkRKBDr7aRQa1-2BEHL-2FpUByliwkTu-2F-2Fgy1rlXnOE1-2Fyw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C37be7db22d15435a50f608dadf4d9ac1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638067821643181248%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=l%2Bw9hcNGV4K73GnVjTijO3%2FP0%2FnvabK%2BdXTJuy46EzA%3D&reserved=0

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/0092

• Date of REC Opinion

  31 Mar 2016

• REC opinion

  Further Information Favourable Opinion