Double hit lymphoma Trials in Disease

Study on Acalabrutinib with Rituximab and Drug Combination for Older Adults with Untreated Diffuse Large B-Cell Lymphoma

This clinical trial is investigating a new treatment approach for older adults with diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, which is also known as double hit lymphoma. The study compares the effectiveness of adding acalabrutinib to a standard reduced-dose chemotherapy regimen called R-miniCHOP.

Main focus: The primary goal of this trial is to determine whether adding acalabrutinib to the R-miniCHOP treatment can help patients live longer without their disease progressing, compared to using R-miniCHOP alone. Participants will be randomly assigned to receive either the combination treatment or R-miniCHOP alone, allowing researchers to compare the outcomes between the two approaches.

Investigational drugs: The trial uses three main treatment components:

• Acalabrutinib – A targeted therapy that blocks a specific protein called Bruton's tyrosine kinase (BTK), which helps cancer cells grow and survive. This medication is taken orally as capsules.
• Rituximab – A medication that targets a protein on the surface of cancer cells, helping the body's immune system destroy them more effectively.
• R-miniCHOP – A reduced-dose combination of chemotherapy drugs including doxorubicin, cyclophosphamide, vincristine sulfate, prednisone or prednisolone, and pegfilgrastim. Each drug attacks cancer cells in different ways, making it harder for the cancer to survive.

Who can participate: This trial is designed for patients who meet specific requirements:

• Adults over 80 years old, or those between 60 and 80 who are not healthy enough for full-dose chemotherapy
• Confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma or related types, including high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
• Disease stage I with a large tumor (at least 7.5 cm), or stage II, III, or IV
• Have not received any previous treatment for this lymphoma
• Meet specific laboratory requirements showing adequate bone marrow, liver, and kidney function
• Able to swallow capsules and tablets without difficulty
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (or 3 if directly caused by the lymphoma)

Who cannot participate: The trial excludes certain individuals:

• Patients younger than 60 years old who are eligible for full-dose chemotherapy
• Those who have already received treatment for diffuse large B-cell lymphoma
• Patients with other types of cancer not specified in the study
• Women who are pregnant or breastfeeding
• Individuals with severe heart problems or uncontrolled medical conditions
• Those with active infections requiring treatment
• Patients with allergies to the study medications
• Those participating in another clinical trial simultaneously

What to expect: The trial follows a structured approach over several phases. Upon joining, participants will be randomly assigned to one of two treatment groups. During the treatment phase, medications are administered in cycles, with some drugs given orally and others through an intravenous line. Throughout the trial, regular monitoring includes physical examinations, blood tests, and imaging studies to evaluate response to treatment and manage any side effects. After completing treatment, follow-up visits are scheduled to monitor long-term health and treatment effectiveness.