The trial is investigating acalabrutinib when used with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Together, this combination treatment is called R-CHOP. R-CHOP is the standard therapy for this form of lymphoma. The combination of acalabrutinib is what makes this therapy novel.
Acalabrutinib is already approved therapy for mantle cell lymphoma, a form of non-Hodgkin lymphoma, as well as an approved therapy for chronic lymphocytic leukemia, a form of leukemia. It works by inhibiting BTK, the enzyme that aids in the growth of the Large-B Cell lymphoma.
This placebo-controlled trial is randomized and double-blind.
All participants must be at no more than 65 years old. Each will receive the standard R-CHOP therapy. Then, half of the patients will receive aclabrutinib and half will receive placebo. This divide will be fully randomized.
Patients who are interested in enrolling must meet the following criteria-
- They must be recently diagnosed with the lymphoma
- They must not have been given any prior treatment for the lymphoma
- They must have the ability to do daily activities such as walk for over half of the hours in a day
- They must be between the ages of 18 and 65
To read the full enrollment criteria, visit clinical trials.gov. You can also contact the principal investigator Dr. Mathew Matasar by calling 212-639-8889. The co-investigator on the trial for Connie Lee Batlevi.
The trial will be held at 5 different locations. You can real more about the details of this investigation and the potential of this investigative therapy here.