Clinical Trial TitleA phase 3 randomized, open-label, multicenter study comparing zanubrutinib plus rituximab versus bendamustine plus rituximab in patients with previously untreated mantle cell lymphoma.
National Clinical Trial Number:NCT04002297
Clinical Trial Protocol Description:
Lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Mantle cell lymphoma (MCL) results from a malignant transformation of a B lymphocyte in the outer edge of a lymph node follicle (the mantle zone). The transformed B lymphocyte grows in an uncontrolled way, resulting in the accumulation of lymphoma cells, which causes enlargement of lymph nodes.
MCL is generally considered an aggressive (fast-growing) type of B-cell NHL and most patients with MCL (70%) have advanced stage disease at their diagnosis. MCL occurs more frequently in older adults—the average age at diagnosis is the mid-60s. It is more often diagnosed in males than in females and white men and women are at a higher risk than black men and women for an MCL diagnosis. For older patients, and those with comorbidities that rule out treatment with standard chemoimmunotherapy regimens and stem cell transplantation have few options, and treatment is largely palliative. No standard approach to treatment has been defined for these patients.
Bruton tyrosine kinase (BTK) is a key receptor in B-cell tumor growth. Kinase inhibitor therapy blocks certain proteins, which may help keep lymphoma cells from growing and may kill them. Zanubrutinib is an inhibitor of Bruton's tyrosine kinase with potential anti-cancer activity. Zanubrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. BTK is overexpressed in B-cell malignancies; it plays an important role in B-lymphocyte development, activation, signaling, growth, spread and survival in the body.
This study is comparing treatment with zanubrutinib plus rituximab followed by zanubrutinib alone versus bendamustine plus rituximab followed by observation. It is for people with previously untreated mantle cell lymphoma who are ineligible for stem cell transplantation due to age or comorbidities. The primary objective is survival without the cancer growing.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 70 years of age or older, or are 65 years of age or older, but younger than 70 with medical issues that prevent you from having an autologous stem cell transplant.
- Have not received prior treatment for your MCL.
- Have adequate organ function.
- Are able to swallow pills.
You will be excluded from the study if any of the following criteria apply to you:
- Have had a previous bone marrow transplant.
- Have had previous treatment with rituximab or bendamustine.
- Have clinically significant cardiovascular disease, prior history of a stroke, or a severe bleeding disorder.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.