OAsIs

• Research type

  Research Study

• Full title

  A phase I/II trial of Obinutuzumab, ABT-199 (GDC-0199) plus Ibrutinib in Relapsed/Refractory Mantle Call Lymphoma patients (OAsIs)

• IRAS ID

  193860

• Contact name

  Phillipe SUDREAU

• Contact email

  bp-prom-regl@chu-nantes.fr

• Sponsor organisation

  Centre Hospitalier Universiaire de Nantes

• Eudract number

  2014-003740-13

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  Mantle Cell Lymphoma (MCL) accounts for approximately 6% of Non Hodgkins Lymphoma (NHL) and which commonly responds to initial therapy, but inevitably the majority of patients relapse, and, with the possible exception of allogeneic bone marrow transplantation, this is not a curable disease. The treatment of choice for younger patients is a high dose cytarabine-containing regimen with consolidation with an autologous stem cell transplant. However as the average age of presentation of this disease is the mid-60's the majority of patients are ineligible for these approaches. Regardless of age or initial therapy there is no widespread consensus on treatment of relapsed disease - which is increasingly chemotherapy resistant. The use of novel targeted agents as in this study may help to overcome this resistance. This study is a first-in man examination of the combination of 3 treatments for relapsed/refractory mantle cell lymphoma (MCL): Obinutuzumab (GA101) [an immunotherapeutic drug] Ibrutinib and ABT199(GDC-0199) [two protein inhibitors which prevent the growth of tumour cells without affecting normal cells.]
  Ibrutinib is a licensed treatment for MCL, Obinutuzumab(GA101) has a license to treat Chronic Lymphocytic Leukaemia (a similar type of cancer), and ABT199(GDC-0199) is undergoing clinical trials to treat several types of lymphoma. The study is based on a cautious recruitment plan to initially test the combination of Ibrutinib and Obinutuzumab(GA101) at standard doses (9 patients), then the addition of ABT199(GDC-0199) in a dose escalation to establish Dose Limiting Toxicity (24 new patients). Patients will be treated for 2 years, then followed up annually for 2 further years. The study is to be carried out in 4 sites in total; 2 in France:Nantes, Bordeaux, and 2 UK sites: Plymouth, Southampton.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  16/EE/0015

• Date of REC Opinion

  4 Mar 2016

• REC opinion

  Further Information Favourable Opinion