Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia

NCT ID: NCT02157324

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-18
• Study Completion Date: 2026-04-01

Brief Summary

This study is evaluating the safety and efficacy of the combined use of acalabrutinib and ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

acalabrutinib

Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

ACP-319

Intervention Type: DRUG

ACP-319

Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

ACP-319

Intervention Type: DRUG

Interventions

acalabrutinib

Intervention Type: DRUG

ACP-319

Intervention Type: DRUG

Other Intervention Names

ACP-196

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years of age with a confirmed diagnosis of CLL, which has relapsed after, or been refractory to, ≥ 1 previous treatments for CLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria

• Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years.
• A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib and/or ACP-319, or put the study outcomes at undue risk.
• Significant cardiovascular disease.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
• Any immunotherapy within 4 weeks of first dose of study drug.
• For subjects with recent chemotherapy or experimental therapy the first dose of study drug must occur after 5 times the half-life of the agent(s).
• History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
• Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of CLL or other conditions. Note: Subjects may be using topical or inhaled corticosteroids as therapy for comorbid conditions.
• Central nervous system (CNS) involvement by CLL.
• Grade ≥ 2 toxicity (other than alopecia).
• Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or any uncontrolled active systemic infection.
• Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
• Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count < 50 x 109/L unless due to disease involvement in the bone marrow.
• Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN unless disease related.
• Significant screening ECG abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, and QTc > 480 msec.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acerta Pharma BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Acerta Clinical Trials

Role: STUDY_DIRECTOR

1-888-292-9613 acertamc@dlss.com

Locations

Research Site

Columbus, Ohio, United States

Research Site

Hermitage, Tennessee, United States

Research Site

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

ACE-CL-002

Identifier Type: -

Identifier Source: org_study_id