Cancer Center Offers Chimeric Antigen Receptor T-Cell Therapy

Cleveland Clinic Cancer Center is now accepting patients for the FDA-approved chimeric antigen receptor (CAR) T-cell therapy, Yescarta™ (axicabtagene ciloleucel).

Yescarta is a CD19-directed CAR T-cell therapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy (including autologous stem cell transplantation). This includes diffuse large B-cell lymphoma(DLBCL), primary mediastinal B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Cleveland Clinic participated in the pivotal phase 2 trial that reported outcomes on 111 patients with relapsed or refractory large B-cell lymphomas. Yescarta was administered to 101 patients (91 percent) with an objective response rate of 82 percent and a complete response rate of 54 percent. At 18 months post-treatment, the overall survival rate was 52 percent.

Severe side effects have been noted, prompting the FDA to require any centers that dispense Yescarta to be specially certified. These serious potential side effects include cytokine release syndrome and neurologic toxicities, both of which can be life-threatening. Building on experience obtained from participation on Yescarta clinical trials, Cleveland Clinic has established a multidisciplinary expert team with training and familiarity in administering this therapy and managing its toxicities.

Patients with relapsed or refractory large B-cell lymphoma should be referred for a consultation preferably prior to initiating second-line therapy. Earlier referral allows us to expedite eligibility evaluation for Yescarta in case the patient does not respond to salvage therapy. Patients with more advanced disease should be referred as soon as possible, including patients whose lymphoma has relapsed or not responded after autologous or allogeneic stem cell transplantation.

For questions about our approach to this therapy, please contact Brian Hill, MD, PhD, Director of the Lymphoma Program at hillb2@ccf.org or 216.445.9451, or Navneet Majhail, MD, MS, Director of the Blood and Marrow Transplant Program at majhain@ccf.org or 216.444.2199.