COSMOS

• Research type

  Research Study

• Full title

  A Phase II, Two Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined with Idelalisib or Venetoclax in Patients with Relapsed or Refractory CLL/SLL Previously Treated with Bruton’s Tyrosine Kinase (BTK) Inhibitor

• IRAS ID

  190267

• Contact name

  Talha Munir

• Contact email

  tmunir@nhs.net

• Sponsor organisation

  MorphoSys AG

• Eudract number

  2015-002915-14

• Clinicaltrials.gov Identifier

  NCT02639910

• Duration of Study in the UK

  5 years, 9 months, 0 days

• Research summary

  Summary of Research
  Chronic lymphocytic leukaemia (CLL) is the most common haematological malignancy (blood cancer). SLL (small lymphocytic lymphoma) is a SLL is a subset of CLL. Chronic lymphocytic leukaemia is not usually curable. But it often develops very slowly and treatment can keep it under control for many years.

  For all stages of CLL, around 70 out of 100 men (70%) and almost 75 out of every 100 women (75%) will survive for 5 years or more after being diagnosed.

  Several treatment combinations are currently available in the UK for a first treatment of newly diagnosed CLL/SLL patients. Many of these combinations involve the use of a Bruton’s Tyrosine Kinase (BTK) Inhibitor such as ibrutinib. However, many patients relapse after a number of treatment combinations. And for a number of patients who are diagnosed with relapsed and refractory CLL, who have previously received a BTK Inhibitor and had to discontinue treatment, the prognosis is particularly poor. Overall, the lack of effective treatment for this patient population constitutes an urgent unmet medical need.

  MOR00208 is an investigation drug, being tested in this clinical trial, meaning that is has not yet been approved for use for this disease. Idelalisib is an approved treatment for CLL/SLL, but is approved in combination with rituximab. MOR00208 in combination with idelalisib has a safety profile which is suitable for the treatment of the mainly elderly patient population. This clinical trial is therefore designed to evaluate the effectiveness of this treatment.

  The treatment population will be CLL/SLL patients who are aged over 18 years and relapsed or refractory disease, who have been previously treated with a Bruton’s Tyrosine Kinase Inhibitor.

  Approximately 120 patients are expected to take part in this trial globally with around 10 of these being UK patients. The trial will be open at approximately 5 hospitals in the UK.

  Summary of Results
  Sponsor have advised that the production of Plain Language Summary is not planned for this study

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  16/YH/0004

• Date of REC Opinion

  19 Feb 2016

• REC opinion

  Further Information Favourable Opinion