ACP-196 with Relapsed or Refractory Chronic Lymphocytic Leukemia
Research type
Research Study
Full title
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia
IRAS ID
212505
Contact name
Abraham Jacob
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2015-004454-17
Duration of Study in the UK
3 years, 7 months, 2 days
Research summary
Chronic Lymphocytic Leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell).
All cells in the body receive signals to grow and survive, but sometimes these signals get out of control, causing too much cell growth. When the growth of lymphocytes gets out of control, cancers like CLL can develop. Medication like rituximab and bendamustine can kill some of the CLL cells and can help control the disease. Medications like acalabrutinib through inhibition of Bruton kinase (Btk) and idelalisib through inhibition of Phosphatidyl Inositol kinase 3 (PI3k) block some of the cell functions that cause CLL to grow and survive and may also help control the disease.
The purpose of this research study is to determine if the experimental medication acalabrutinib is safe and effective in the treatment of this disease in comparison with the approved treatment of rituximab with either idelalisib or bendamustine. The participant will come to the clinic/hospital throughout the study for certain tests and procedures. These visits and procedures will vary based on which study arm they are participating in.
Approximately 306 eligible male and female participants aged 18 years or older will be enrolled. Patients will be randomised in a 1:1 ratio into 2 arms of the study. The participants will receive either:
Arm A: Acalabrutinib 100 mgwill be taken orally twice a day until an unacceptable medication-related toxicity occurs or until disease progression.Arm B: Before randomisation investigator’s choice of:
• Idelalisib 150 mg administered twice a day until disease progression or unacceptable toxicity in combination with ≤ 8 IV infusions of rituximab.
• Bendamustine 70 mg/m2 thorough a needle into a vein (IV)(Day 1 and 2 of each cycle) in combination with rituximab IV (375 mg/m2 cycle 1/500 mg/m2 cycle 2 onwards) on Day 1 of each cycle for up to 6 cycles.Following the end of the study the study doctor may seek to establish the participants long term health status for a period of not more than 48 months. This may be done by accessing the participants hospital records, or publicly available sources such as national registries, newspaper obituaries and social networking websites. Attempts may also be made to contact them or their relatives to ascertain this information. The maximum duration of this study is 48 months from the first participant randomised.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/1717
Date of REC Opinion
26 Oct 2016
REC opinion
Favourable Opinion