ACP-196 as mono and combination therapy in untreated CLL patients

  • Research type

    Research Study

  • Full title

    A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP-196 in Combination with Obinutuzumab, and ACP-196 Monotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia

  • IRAS ID

    182025

  • Contact name

    Tahla Munir

  • Contact email

    tmunir@nhs.net

  • Sponsor organisation

    Acerta Pharma BV

  • Eudract number

    2014-005582-73

  • Clinicaltrials.gov Identifier

    118717, IND number

  • Duration of Study in the UK

    4 years, 1 months, 1 days

  • Research summary

    Chemoimmunotherapy has become a standard for the treatment of young and/or fit individuals with CLL who require treatment. Elderly subjects and those with pre-exisiting diseases are often unable to tolerate combination chemoimmunotherapy regimens, or experience inferior outcomes. ACP-196 has recently been identified as an orally administered Btk1 inhibitor that selectively blocks Btk1 (an enzyme indicated in the progression of CLL) so reducing potential for off-site side effects seen with other treatments.
    ACP-196 has been well tolerated in healthy volunteers and patients and has shown sustained improvement in symptoms of CLL.

    This study, sponsored by Acerta Pharma, will investigate safety and effectiveness of ACP-196 as a single or combination therapy compared to approved treatments. 510 patients over the age of 18 at approximately 120 sites globally will be randomised in a 1:1:1 ratio to receive either obinutuzumab in combination with chlorambucil per the package inserts, ACP-196 100 mg twice per day in combination with obinutuzumab per the package insert, or ACP-196 100 mg twice daily. Each patient will give informed consent and will be screened for suitability and will be in the study for approximately 4 years unless early withdrawal is necessary. Patients will have response evaluations every 12 weeks for the first 24 months and then every 24 weeks thereafter. Patient will also and undergo tests per the schedule in the study protocol such as physical examinations, vital signs, complete diaries and questionnaires, blood tests for safety and effectiveness of study drugs, CT scans and ECG.

  • REC name

    North West - Greater Manchester Central Research Ethics Committee

  • REC reference

    15/NW/0468

  • Date of REC Opinion

    3 Jul 2015

  • REC opinion

    Further Information Favourable Opinion