Lancet Haematol: Avadomide joint obinutuzumab treatment recurrent or refractive non-Hodgkin lymphoma.

Avadomide (CC-122) is a new type of oral neuromodulator with broad prospects in non-Hodgkin's lymphoma.
this study was designed to assess the safety and initial activity of avadomide in patients with recurrent or incurable non-Hodgkin's lymphoma.
this is a phase 1b dose increase and expansion study conducted at eight centres in France, Italy and the Netherlands to recruit patients with recurrent/refractive non-Hodgkin lymphoma with a diagnosed CD20 plus over the age of 18.
in the dose expansion phase, only recurrent/incurable follicle lymphomas (grades 1, 2 or 3a) that have been treated in the past are included.
Avadomide is administered in two formulas in incremental doses for 5 days, 2 days, 28 days/treatment.
Obinutuzumab 1000 mg static drops, the first day of the first course of treatment, the 2nd, 8th and 15th days and the 2-8 treatment.
primarily aimed at clarifying the safety and tolerance of Avadomide, the maximum tolerable dose and the recommended phase 2 dose (RP2D).
(Avadomide's method and dose) June 24, 2015 -December 5, 2018, a total of 73 patients were recruited: 19 diffuse large B cell lymphomas, 53-level follicular lymphoma, and 1 peripheral lymphoma.
median follow-up for 253 days. the median number of
anti-tumor treatments is 3 times.
tolerability dose was not reached.
based on safety and pharmacodic dynamics data, the RP2D of avadomide and Obinutuzumab was 3.0 mg when combined.
the extended queue receive the RP2D dose.
three patients developed dose-limiting toxicity, one of whom was treated with an RP2D dose (stage 3 sepsis).
most common level 3 adverse reactions were a decrease in neutral granulocytes (56%) and a decrease in plateboard (23%).
34 (47%) patients had severe adverse reactions, of which 23 (32%) were considered to be avadomide-related and 20 (27%) were considered to be associated with Obinutuzumab.
two treatment-related deaths, one from a tumor attack and one from acute myeloid leukemia after the end of the study.
Summary: Avadomide and Obinutuzumab have controlled toxicity and are tolerable to most patients.
Although the efficacy threshold did not meet expectations, the researchers believe that the brain neuromodulator combined with second-generation anti-CD20 monotonicaination for recurrent/refractory non-Hodgkin's lymphoma antitumor activity is worthy of further study.
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