New hope for chinese patients with Hard-to-Treat blood cancers
NCT ID NCT03932331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called acalabrutinib in Chinese adults with certain blood cancers (mantle cell lymphoma, chronic lymphocytic leukemia, or other B-cell cancers) that have come back or not responded to treatment. The trial has two parts: the first checks safety and how the drug moves through the body, and the second looks at how well it shrinks tumors. About 105 participants will take acalabrutinib pills twice a day.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acalabrutinib (a targeted cancer drug taken as a pill)
- What this could lead to
- If successful, this could provide a new treatment option for Chinese patients with certain blood cancers that have not responded to prior therapy.
- What could go wrong
- This is an early-phase study (Phase 1/2) with a small number of participants, so results may not apply broadly. Side effects are possible, and the drug may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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105 people
The number who actually took part.
- Started
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Apr 2020
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. 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. 2. Chinese subjects at least 18 years of age at the time of study entry. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 4. Adequate hematological and organ function. 5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy. 6. 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. 7. Diagnosis of CLL that meets published diagnostic criteria. Must have received ≥ 1 prior systemic therapies for CLL. 8. Active disease per iwCLL 2018 criteria that requires treatment. (CLL only) 9. Other relapsed/refractory B-cell malignancies without stand of care (phase 1 only). Exclusion criteria 1. 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. 2. Significant cardiovascular disease. 3. Known central nervous system involvement of lymphoma/leukemia or leptomeningeal disease. 4. Known history of HIV, serologic status reflecting active hepatitis B or C infection. 5. Major surgery within 4 weeks before first dose of study drugs. 6. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. 7. Required or received anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon). 8. Prior exposure to a BCR or BCL-2 inhibitor. 9. Use of a strong inhibitor or inducer of CYP3A. 10. Breastfeeding or pregnant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Beijing, 100044, China
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Research Site
Beijing, 100142, China
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Research Site
Beijing, 100191, China
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Research Site
Changchun, 130021, China
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Research Site
Changsha, 410008, China
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Research Site
Changzhou, 272100, China
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Research Site
Chengdu, 610041, China
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Research Site
Fuzhou, China
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Research Site
Haikou, 570311, China
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Research Site
Hangzhou, 310003, China
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Research Site
Hangzhou, 310022, China
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Research Site
Harbin, 150049, China
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Research Site
Hefei, 230031, China
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Research Site
Hohhot, 10050, China
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Research Site
Nanchang, 330006, China
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Research Site
Nanjing, 210029, China
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Research Site
Shanghai, 200032, China
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Research Site
Suzhou, 215006, China
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Research Site
Tianjin, 300020, China
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Research Site
Tianjin, 300060, China
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Research Site
Ürümqi, 830054, China
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Research Site
Xining, 810007, China
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Research Site
Zhengzhou, 450008, China