Mantle Cell Lymphoma MCL
Conditions
Interventions
Protocol treatment: 100mg ACP-196 twice daily
Sponsors
ACERTA PHARMA B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Men and women >= 18 years of age. • Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1. • Disease has relapsed after or been refractory to >= 1 prior therapy for MCL and now requires further treatment. • Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen. • Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of >= 1 lesion that measures >= 2.0 cm in the longest dimension and >= 1.0 cm in the longest perpendicular dimension as assessed by computed tomography [CT] scan). • At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects having received >= 2 cycles of prior treatment with bortezomib or any other commercially available proteasome inhibitor, either as a single agent or as part of a combination therapy regimen, will be considered to be proteasome inhibotor-exposed.) • Eastern Cooperative Oncology Group (ECOG) performance status of
Exclusion criteria
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 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation. • 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. • Major surgery within 4 weeks before first dose of ACP-196. • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. • History of stroke or intracranial hemorrhage within 6 months before the first dose of ACP-196. • Requires anticoagulation with warfarin or a vitamin K antagonist. • Absolute neutrophil count (ANC) 2.5 x institutional upper limit of normal (ULN); total bilirubin > 2.5 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 electrocardiogram (ECG) abnormalities including atrial fibrillation, 2nd-degree AV block type II, 3rddegree AV block, Grade >= 2 bradycardia, or QTc > 480 msec. • Breastfeeding or pregnant. • Concurrent participation in another therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the activity of acalabrutinib in subjects with relapsed/reractory (R/R) MCL as measured primarily by response rate. In addition, activity of acalabrutinib will be assessed by duration of response, progression-free survival and overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To characterize the safety profile of acalabrutinib * To characterize the pharmacokinetic (PK) profile of acalabrutinib * To evaluate the PD effects of acalabrutinib | — |
Countries
Netherlands
Outcome results
None listed