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

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Acerta Pharma

Status and phase

Active, not recruiting
Phase 1


Chronic Lymphocytic Leukemia


Drug: ACP-319
Drug: acalabrutinib

Study type


Funder types




Details and patient eligibility


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)


12 patients




18+ years old


No Healthy Volunteers

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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

12 participants in 2 patient groups

Experimental group
Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.
Drug: acalabrutinib
Drug: ACP-319
Experimental group
Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.
Drug: acalabrutinib
Drug: ACP-319

Trial contacts and locations



Data sourced from

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