ACE-CL-311

ACE-CL-311

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

Disease:

Chronic Lymphocytic Leukemia (Untreated)

Summary:

Chronic lymphocytic leukemia  (also called CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL is a blood and bone marrow disease that usually gets worse slowly. CLL is one of the most common types of leukemia in adults and it often occurs during or after middle age.

The purpose of this study is to evaluate the efficacy and safety of Acalabrutinib in combination with Venetoclax with and without Obinutuzumab compared to standard chemoimmunotherapy in subjects with previously untreated Chronic Lymphocytic Leukemia

Eligibility:

Include, but not limited to, the following:

Inclusion Criteria:
1. Men and women ≥18 years of age.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
3. Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)
4. Active disease per IWCLL 2018 criteria that requires treatment.
5. Participants must use highly effective birth control throughout the study.

Exclusion Criteria:
1. Any prior CLL-specific therapies.
2. Detected del(17p) or TP53 mutation.
3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia [PLL], or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia.
4. History of confirmed progressive multifocal leukoencephalopathy (PML).
5. Received any investigational drug within 30 days before first dose of study drug.
6. Major surgical procedure within 30 days before the first dose of study drug.
7. Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
8. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
9. Received a live virus vaccination within 28 days of first dose of study drug.
10. Known history of infection with human immunodeficiency virus (HIV).
11. Serologic status reflecting active hepatitis B or C infection.
12. History of known hypersensitivity or anaphylactic reactions to study drugs or excipients.
13. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
14. Known bleeding disorders.
15. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
16. Female participants must not be breastfeeding or pregnant.
17. Concurrent participation in another therapeutic clinical trial.

Contact person:

Louise Hay
Email Louise.hay@health.wa.gov.au
Phone 08 6383 3207


Email
Phone

Principal Investigator:

Dr Gavin Cull

08 6457 7600

Sponsor:

Acerta Pharma BV

Phase:

Three

Protocol Number:

ACE-CL-311 (D8221C00001)

Trial Registration Number:

NCT03836261

Clinical Trials.gov

ANZ Clinical Trial Registry