RecruitingNot ApplicableNCT05950997

A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL

A Single Arm Study of Acalabrutinib Combined With Obinutuzumab in Chinese Patients With Treatment-Naive Chronic Lymphocytic Leukemia


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

89 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, prospective study to assess the efficacy and safety of acalabrutinib combined with obinutuzumab in subjects with previously untreated chronic lymphocytic leukemia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — acalabrutinib and obinutuzumab — as a first treatment for Chinese patients with chronic lymphocytic leukemia (CLL), a slow-growing type of blood cancer. Both drugs target cancer cells in different ways and together may be more effective than older treatment options. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of CLL that requires treatment - You have never been treated for CLL before (prior local radiotherapy is allowed) - Your overall health is adequate (ECOG 0-2) with no recent significant decline - Your blood counts, kidney, and liver function meet required levels - You are able to swallow capsules and tablets **You may NOT be eligible if...** - You have previously received any systemic treatment for CLL - You are HIV positive or have active hepatitis B or C - You have had a stroke or bleeding in the brain in the past 6 months - You have a bleeding disorder such as hemophilia - You are taking blood thinners like warfarin - You need proton pump inhibitors (like omeprazole) that cannot be stopped - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

100 mg capsules administered by mouth once daily (28-day cycles)

DRUGObinutuzumab

100 mg administered intravenously on Day 1 and 900 mg administered intravenously on Day 2, 1000 mg administered intravenously on Day 8 and 15 of cycle 2 and 1000 mg on Day 1 of subsequent cycles for a total of 6 cycles (28-day cycles)


Locations(1)

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjin, Jiangsu, China

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NCT05950997


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