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



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:August 2014

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A Multicenter, Open-label, Phase 1 Pilot Study of ACP-196 in Combination With ACP-319 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

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)


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.
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