Efficacy of Acalabrutinib in patients with CLL

• Research type

  Research Study

• Full title

  A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation

• IRAS ID

  261281

• Contact name

  Moya Young

• Contact email

  moya.young@nhs.net

• Sponsor organisation

  AstraZeneca

• Eudract number

  2018-002443-28

• Clinicaltrials.gov Identifier

  NCT03836261

• Duration of Study in the UK

  4 years, 9 months, 2 days

• Research summary

  The purpose of this study is to determine if giving an experimental drug called acalabrutinib in combination with venetoclax with and without obinutuzumab compared to current standard of care treatments which include either a combination of bendamuztine and rituximab (BR) or a combination of Fludarabine, Cyclophosphamide and Rituximab (FCR), is safe and effective for treating people with CLL (chronic lymphocytic leukemia) who have never received any prior treatment.
  After they sign the informed consent form, patients will undergo a screening visit. Patients fulfilling eligibility criteria at cycle 1 will be randomized and receive open-label medication.

  This study has three arms, Arm A, Arm B and Arm C.
  In Arm A and Arm B of the study, patients will take a total daily dose 200mg Acalabrutinib (for 36cycles) and 400mg Venetoclax (for 24 cycles). Venetoclax will start at cycle 3 with a ramp-up phase of 4 weeks, where the daily dose is elevated each week. A singe course or “cycle” of study drug treatment is 28 days.

  In Arm B Obnutuzumab will be given as IV therapy (intravenous therapy) for 6 cycles from cycle 2-7, in addition to Acalabrutinib and Venetoclax.

  Patients randomized Arm C will receive 1 of 2 standard chemoimmunotherapy treatments for a maximum of 6 cycles, the treatment will be decided by the study doctor. One of the treatments consists of medications called Fludarabine, cyclophosphamide and rituximab (FCR) and the other consists of medications called bendamustine and rituximab (BR).

  The duration of each patient is depending on the treatment they are randomized to:
  -Arm A and B:patients will have about 40-42 visits over approximately 3 years.
  -Arm C : There will be 15-19 visits over approximately 6 months.

  After being discontinued from the study drug, patients will be followed up for disease progression (if applicable) and survival status.

  The research study is planned to go for approximately 5 years and include around 780 patients with CLL from approximately 30 countries.
  

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  19/YH/0168

• Date of REC Opinion

  19 Jun 2019

• REC opinion

  Favourable Opinion