Julie Chang, MD, discusses the reasoning behind the development of a minimal residual disease-adapted study in patients with previously untreated mantle cell lymphoma.
Julie Chang, MD, associate professor of medicine at the University of Wisconsin School of Medicine and Public Health, discusses the reasoning behind the development of a minimal residual disease (MRD)-adapted study in patients with previously untreated mantle cell lymphoma (MCL).
In the trial, clonoSEQ assessed MRD status in peripheral blood was used to establish a link between early response and outcomes. Additionally, it guided maintenance therapy decisions in patients with previously untreated MCL.
The study included 21 patients. Patients with a complete response (CR) who were MRD-negative by clonoSEQ following induction and consolidation therapy were treated with maintenance. Patients who did not have a CR or persistent MRD positivity received maintenance with obinutuzumab for a total of 8 cycles. Further, the study followed patients for ≥2 years from therapy completion.
According to Chang, the study focuses on providing more tolerable frontline therapy options for older patients ineligible for intensive treatments, using a combination of the novel monoclonal antibody obinutuzumab and bendamustine. The study also aims to investigate whether MRD testing can serve as a predictor for the need of maintenance therapy.
0:10 | We know that patients who are older and not eligible for intensive therapies can have limited options for frontline therapy that's tolerable. We were very interested in using the novel monoclonal antibody, obinutuzumab [Gazyva] and combining it with bendamustine [Bendeka]. We know that from the results of the GALLIUM study [NCT01332968] in other types of low-grade non-Hodgkin lymphomas that resulted in better progression-free survival compared with bendamustine and rituximab [Rituxan]. We were hoping to capitalize on that same benefit in [patients with] mantle cell lymphoma.
0:45 | We are also interested in seeing if minimal residual disease testing could predict the need for maintenance therapy. Maintenance therapy has been very controversial, or there's been mixed data about the benefit of that modality, so we are very interested in seeing if there was some biological predictor for benefit.