Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

Korábbi kezelés

• Major surgery within 4 weeks before first dose of study drugs.
• Required or received anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon).
• Prior exposure to a BCR or BCL-2 inhibitor.
• Use of a strong inhibitor or inducer of CYP3A.

Más betegség

• Significant cardiovascular disease.
• Known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease.
• Known history of HIV, serologic status reflecting active hepatitis B or C infection.
• Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.

Életkor

• Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject had been disease free for ≥2 years or which would not have limited survival to <2 years.

Egyéb

• Breastfeeding or pregnant.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Chinese subjects at least 18 years of age at the time of study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
• Adequate hematological and organ function.
• Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
• Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14) (q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5). Disease had relapsed after or been refractory to previous treatment.
• Diagnosis of CLL that meets published diagnostic criteria. Must have received ≥ 1 prior systemic therapies for CLL.
• Active disease per iwCLL 2018 criteria that requires treatment. (CLL only)
• Other relapsed/refractory B-cell malignancies without stand of care (phase 1 only).