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Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
80 patients around the world
Available in Puerto Rico, Brazil
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with
acalabrutinib in combination with rituximab in a single arm.
Study details include the following:
- The study duration will be up to 108 weeks for each patient, including up to 28 days
for screening and 104 weeks of treatment and follow-up.
- The treatment duration will be up to 8 cycles for rituximab and 28 cycles for
acalabrutinib both beginning at cycle 1.
AstraZeneca
80Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Diffuse large B-cell lymphoma
Requirements for the patient
To 99 Years
All Gender
Medical requirements
- ≥ 80 years of age at the time of screening.≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy.Histologically documented DLBCL.No prior treatment for DLBCL.Stage II, III, or IV disease by the Ann Arbor Classification.Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.
- Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.Serologic status reflecting active hepatitis B or C infection.Known to have tested positive for HIV.Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of > 6.History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.Known history of infection with HIV or any active significant infection.History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.History of bleeding diathesis (eg, haemophilia, von Willebrand disease).Any concurrent anticancer treatment.Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.Received a live virus vaccination within 28 days of the first dose of study drug.
StudyACRUE
SponsorAstraZeneca
Conditions
Diffuse large B-cell lymphoma
Requirements
To 99 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05952024
