NCT03932331Active, not recruitingPhase 1/2
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
This is an open-label, two-part study to assess the safety, tolerability, pharmacokinetics and clinical efficacy of acalabrutinib in Chinese adult subjects with R/R MCL, CLL and other B-cell malignancies. The study is divided into 2 parts: Phase 1 portion and Phase 2 portion.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 16 Apr 2019
- Start date
- 29 Apr 2020
- Primary completion date
- 22 Dec 2022
- Lead sponsor
- AstraZeneca
- NCT number
- NCT03932331
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 105
- From 29 Apr 2020 to the primary completion date, 22 Dec 2022
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Age
- 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.
Other
- Breastfeeding or pregnant.
Who the study is looking for
- 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).
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.