An intravenous consolidation regimen developed for patients with chronic lymphocytic leukemia (CLL) was found to be safe and effective, according to a report in the European Journal of Hematology (2017;98:254-262).
Patients with CLL treated with chemo-immunotherapy drugs – such as fludarabine – often show improved rates of long-lasting remission. However, no current therapeutic, curative approaches exist for CLL other than allogeneic transplantation. Previous studies have shown that consolidation therapies may extend progression-free survival (PFS) and long-term survival in this population.
Othman Al-Sawaf, MD, and Kirsten Fischer, MD, both with the department of internal medicine, University of Cologne (Germany), and colleagues conducted a phase I/II trial to assess the effectiveness of consolidation therapy with intravenous alemtuzumab in patients with CLL with complete or partial second remission after fludarabine-based chemo-immunotherapy. A total of 13 patients in complete or partial remission received alemtuzumab in escalating doses, beginning with 10 mg once weekly for 8 weeks and increasing in 10-mg intervals per dose level. The goal of the trial was to determine the maximal tolerable dose of alemtuzumab consolidation after assessing for safety and efficacy in patients who responded to fludarabine-based second-line treatment.
Results of the trials showed the maximal tolerable dose was determined at 10 mg. With alemtuzumab consolidation, 7 of the patients (53%) were in complete remission. Four of such patients (30.7%) achieved minimal residual disease negativity. At a median follow-up of 71.5 months, 4 patients were progression-free, with a median PFS of 28.5 months after the end of second-line treatment.
No long-term toxicity was reported, with the exception of one case of temporary autoimmune vasculitis and hepatitis, which occurred 11 months after the last alemtuzumab administration and was successfully treated with corticosteroids.
Researchers concluded that consolidation therapy with low doses (10 mg/week) of alemtuzumab can be an effective option in patients with CLL after second-line therapy. Other alternative approaches, such as those involving CD20 antibodies, may aid in consolidation response for such patients, they suggest. – Zachary Bessette